Others titles

  • Medical Devices Adverse Events
  • Medical Devices Adverse Events Reports
  • Medical Devices Experience Reports

Keywords

  • MAUDE
  • Device Experience
  • MAUDE Manufacturer Reports
  • MDR
  • Medical Device Events
  • Medical Device Deaths

Medical Device Reporting

Medical Device Reporting

The Medical Device Reporting (MDR) dataset lists the Center for Devices and Radiological Health CDRH’s database information on medical devices which may have malfunctioned or caused a death or serious injury during the years 1984 through 1996.

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Description

The Medical Device Reporting dataset contains information from CDRH’s device experience reports on devices which may have malfunctioned or caused a death or serious injury.

The dataset contains reports received under both the mandatory Medical Device Reporting Program (MDR) from 1984 – 1996, and the voluntary reports up to June 1993. The database currently contains over 600,000 reports.

The FDA is required under the Freedom of Information and Privacy Acts (SEC 552, Title 5, USC) (PL 93-579) to delete, prior to public disclosure, any information that constitutes trade secrets, and confidential, commercial, or financial information; and any personal, medical and similar information that would constitute a clearly unwarranted invasion of personal privacy. Included in the deletion requirements are all identification of the reporters of the events.

About this Dataset

Data Info

Date Created

1997
Last Modified

1997-12-02
Version

1997-12-02
Update Frequency

Never
Temporal Coverage

1984 to 1996
Spatial Coverage

United States
Source

John Snow Labs; U.S. Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A
Source Citation

N/A
Keywords

MAUDE, Device Experience, MAUDE Manufacturer Reports, MDR, Medical Device Events, Medical Device Deaths

Other Titles

Medical Devices Adverse Events, Medical Devices Adverse Events Reports, Medical Devices Experience Reports

Data Fields

Name Description Type Constraints
Access_Type_And_Numberthe report access numberstringrequired : 1
Date_ReceivedReceived Datedaterequired : 1
Product_DescriptionEvent product descriptionstring-
Manufacturer_Name_CodeProduct manufacturer name codestringrequired : 1
Manufacturer_NameProduct manufacturer namestring-
Street_AddressProduct manufacturer Street Addressstring-
CityProduct manufacturer Citystring-
StateProduct manufacturer Statestring-
ZipcodeProduct manufacturer Zip codestring-
Report_TypeReport type, varies from malfunction to deathstring-
Model_NumberMedical device model numberstring-
Catalog_NumberCatalog numberstring-
FDA_Panel_CodeFDA panel codestring-
FDA_Product_CodeFDA product codestringrequired : 1
Event_Description_TypePrecise if Event description type is preliminary or finalstring-
Event_DescriptionDescription of the event linked to the medical devicestring-
Closeout_TextOther important commentsstring-

Data Preview

Access Type And NumberDate ReceivedProduct DescriptionManufacturer Name CodeManufacturer NameStreet AddressCityStateZipcodeReport TypeModel NumberCatalog NumberFDA Panel CodeFDA Product CodeEvent Description TypeEvent DescriptionCloseout Text
M7656831997-01-03ARTIFICIAL URINARY SPHINCTERAMERMEDISYSTAMERICAN MEDICAL SYSTEMS10700 BREN ROAD WESTMINNETONKAMN55343SERIOUS INJURY800GASTROENTEROLOGY-UROLOGYEZYFINALTHE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE. OTHER RELEVANT HISTORY, INCLUDES POST PROSTATECTOMY AND POST TUR; TURP; TURS. IMPLANT DATE IS 12/27/95. EXPLANT DATE IS 2/5/96.
M8856711997-01-02VENTAK MINI+ IMPLANTABLE CARDIOVERTER DEFIBRILLATOCARDPACECARDIAC PACEMAKERS, INC.4100 HAMLINE AVE NST. PAULMN55112MALFUNCTION1741CARDIOVASCULARLWSFINALIMPLANTABLE CARIOVERTER DEFIBRILLATOR (ICD) HAS BEEN IDENTIFIED AS POSSIBLY CONTAINING RESIDUAL GASES (ARGON AND HELIUM) WHICH SHOULD HAVE BEEN REPLACED WITH NITROGEN DURING THE MANUFACTURING PROCESS. THIS COULD CAUSE ELECTRICAL STRESS DAMAGE DURING THE SERVICE CHARGING PROCESS. DR WAS NOTIFIED AND THE PT WAS BROUGHT IN FOR TESTING. THREE CAPACITOR REFORMS WERE PERFORMED, DEFIBRILLATION THRESHOLDS RE-TESTED, AND NORMAL DEVICE WAS OPERATION WAS CONFIRMED. DR ELECTED TO LEAVE THE DEVICE IMPLANTED AT THIS TIME. THE DR WILL PERFORM MANUAL CAPACITOR REFORMS. THE NORMAL FOLLOW-UP SCHEDULE WILL BE FOLLOWED. THIS EVENT WAS REPORTED AFTER REVIEW OF RECORDS SHOWS THAT THE EVENT HAD NOT BEEN REPORTED EARLIER. THE DEVICE WAS TESTED AND OPERATES WITHIN SPEC AT THIS TIME.
M8856801997-01-04REDY 2000GAMBHEALGAMBRO HEALTHCARE1185 OAK ST.LAKEWOODCO80215MALFUNCTIONREDY 2000604487-006GASTROENTEROLOGY-UROLOGYFKPFINALAT THE BEGINNING OF A DIALYSIS TREATMENT, THE FACILITY NOTICED THAT THE "TOTAL UF (ULTRAFILITRATION) WAS NOT READING. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION. THIS MDR WAS ORIGINALLY REPORTED TO THE MFR ON 5/23/96, HOWEVER, THE MFR DETERMINED ALL RELATED COMPLAINTS TO BE MDR REPORTABLE AFTER THE NEW MDR REGULATIONS TOOK INTO EFFECT. THIS MDR WAS ALSO NOT REPORTED WITHIN THE ALLOTTED TIME PERIOD. DEVICE DISCARDED-UNABLE TO FOLLOW-UP. THE MEDICAL EQUIPMENT SERVICE TECH (MES) REPLACED THE LOAD CELL AND CALIBRATED TO MANUFACTURING SPECS. THERE WERE NO RELATED CPF DEFECTS REPORTED ON THIS MACHINE. THE AFFECTED LOAD CELL ASSEMBLY WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE THE MES DISCARDED IT UPON REPLACEMENT. WITHOUT THE AFFECTED COMPONENT AN EVALUATION AS TO THE FAILURE MODE COULD NOT BE DETERMINED. IF THE LOAD CELL WAS DEFECTIVE A LOAD CELL CIRCUIT ALARM WOULD BE GENERATED. THIS ALARM CONSISTS OF A STEADY AUDIBLE ALARM, THE TOTAL UF DISPLAY FLASHES, THE ULTRAFILTRATION CONTROL IS DISABLED, AND THE MACHINE ENTERS BY-PASS AS STATED IN THE DEVICE. IF THE MACHINE DOES NOT FIND A DEFECT IN THE LOAD CELL CIRCUIT THIS ALARM WILL NOT BE GENERATED. HOWEVER, ANY FLUCUATIONS IN THE LOAD CELL DURING A TREATMENT WILL BE NOTICED IN THE UF RATE. HOWEVER, ANY FLUCUATIONS IN THE LOAD CELL DURING A TREATMENT WILL BE NOTICED IN THE UF RATE. IF THE LOAD CELL STOPPED READING AT A CERTAIN POINT THE UF CIRCUIT WOULD TRY TO COMPENSATE AND THE UF RATE WOULD INCREASE. IF THE UF RATE DOES NOT STOP INCREASING THE MACHINE WOULD GENERATE A HIGH UF RATE ALRM. IN THIS INCIDENT, FOR AN UNKNOWN REASON, THE UF RATE STOPPED INCREASING, THERFORE THE ALARM DID NOT OCCUR. THE UF RATE ALARM ENTAILS A STEADY AUDIBLE ALARM AND THE MACHINE ENTERS THE BY-PASS MODE. AS STATED IN THE DEVICE. (*)
M8856811997-01-15COBE CENTRYSYSTEM 3GAMBHEALGAMBRO HEALTHCARE1185 OAK ST.LAKEWOODCO80215MALFUNCTION333100-001GASTROENTEROLOGY-UROLOGYFIIFINALDURING A DIALYSIS TREATMENT, A FOUR POSITION LINE CLAMP BROKE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION. THIS MDR WAS ORIGINALLY REPORTED TO THE MFR ON 6/5/96. HOWEVER, THE MFR HAS DETERMINED THIS COMPLAINT TO BE MDR REPORTABLE AFTER THE NEW REGULATIONS TOOK INTO EFFECT. THIS MDR WAS ALSO INADVERTENTLY NOT REPORTED WITHIN THE ALLOTED TIME PERIOD. DEVICE FAILURE DIRECTLY CAUSED EVENT. THE LIP THAT HOLDS THE CAM IS EITHER WORN AND/OR BROKE OFF AND THE CAMS ARE FALLING OUT OR NOT OCCLUDING THE TUBING SET. THERE WERE NO RELATED CPF DEFECTS REPORTED FOR THIS MACHINE. THE FOUR-POSITION LINE CLAMP WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE IT WAS DISCARDED UPON REMOVAL, IT INDICATES THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE REPORTED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. THE OPERATOR'S MANUAL RECOMMENDS THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLED CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PT CAN RESULT. (*)
M8856851997-01-06GUARDIANGUARPRODGUARDIAN PRODUCTS4175 GUARDIAN ST.SIMI VALLEYCA93063MALFUNCTION30756P30756PPHYSICAL MEDICINEITJFINALUSER CLAIMS THAT WALKER LEG SNAPPED. FOUND AS A RESULT OF INTERNAL AUDIT OF COMPLAINT FILES. FAILURE MODE DETERMINED TO BE DUCTILE DUE TO IMPACT - NOT A FATIGUE FAILURE. WALKER WILL NOT SEE ANY IMPACT IN ANY NORMAL OR HEAVY USE. DETERMINATION IS THAT FAILURE OCCURED DUE TO ABNORMAL USE OR ABUSE. VERY POSSIBLE THAT USER LOST BALANCE AND FELL ON UNIT. STIFFENING INSERT IMPROVED IN ATTEMPT TO STRENGTHEN THIS AREA BEYOND ITS NORMAL INTENDED USE REQUIREMENT. TYPE OF REPORTABLE EVENT: BRUISE.
M7657461997-01-21SIDEKICK IIPRIDHEALCAREPRIDE HEALTH CARE, INC.182 SUSQUEHANNA AVEEXETERPA18643SERIOUS INJURYSC213SC213PHYSICAL MEDICINEINIFINALENDUSER CLAIMS SHE FELL OFF SCOOTER TWO OR THREE TIME INJURING HER NECK. SHE IS NOW WEARING A BRACE. A REP WAS SENT TO THE PTS HOME TO EVALUATE THE DEVICE. THE REP TESTED THE DEVICE UNDER THE CONDITIONS INDICATED BY THE USER AND COULD NOT DUPLICATE THE EVENT. NO REMEDIAL ACTION WAS TAKEN.
M7657451997-01-21PRIDE GENTLE LIFT RECLINERPRIDHEALCAREPRIDE HEALTH CARE, INC.182 SUSQUEHANNA AVEEXETERPA18643SERIOUS INJURYGENERAL HOSPITALFSAPRELIMINARYFELL OUT OF LIFT CHAIR. FRACTURED LUMBER. THIS IS AN EVENT THE CHAIR HAS INVOLVED BUT ALL INDICATIONS ARE THAT THE CHAIR WAS NOT THE ROOT CAUSE OF THE EVENT. MANUFACTURE DATE: 6/15/94.
M7657601997-01-22SILASTIC (R) MAMMARY PROSTHESISDOWCORNDOW CORNING CORP.2200 WEST SALZBURG ROADAUBURNMI48611SERIOUS INJURYUNKGENERAL AND PLASTIC SURGERYFTRFINALPT ALLEGES HAVING A BAD INFECTION IN 1971, HER BREASTS HAVE GOTTEN HARDER, SHE HAS FIBROUS TISSUE, HAS BEEN DIAGNOSED WITH AUTOIMMUNE DISEASE, HAS THYROID CANCER, HER GALLBLADDER WAS REMOVED, SHE HAD A HYSTERECTOMY AND A LIVER TRANSPLANT. PT ALSO ALLEGES DUE TO HER LIVER TRANSPLANT, SHE IS UNABLE TO HAVE REMOVAL OF HER IMPLANTS. ATTY ALLEGES PT'S PHYSICAL INJURIES INCLUDE CHRONIC FATIQUE, BURNING OR ACHING IN THE BREAST AREA, HEADACHES, RECURRENT FLU-LIKE SYMPTOMS, MENTAL ANGUISH, FEAR, PAIN AND DISFIGUREMENT.
M7657591997-01-22SILASTIC (R) MSI MAMMARY IMPLANT, H.P.DOWCORNDOW CORNING CORP.2200 WEST SALZBURG ROADAUBURNMI48611SERIOUS INJURYUNKGENERAL AND PLASTIC SURGERYFTRFINALPT HAD INFLAMMATION IN HER JOINTS. NO DEVICE RETURNED, NO CONCLUSION CAN BE DRAWN.THESE DEVICES ARE NO LONGER COMMERCIALLY AVAILABLE AND CAN ONLY BE USED UNDER CONTROLLED CLINICAL TRIALS. THESE TYPES OF EVENTS USUALLY INVOLVE KNOWN COMPLICATIONS WHICH DO NOT JUSTIFY IMMEDIATE ACTION OR REVIEW OF THE INDIVIUAL REPORT. HOWEVER, THE EVENT AND OTHER SIMILAR EVENTS ARE AVAILABLE FOR FURTHER STATISTICAL ANALYSIS AND MONITORING.
M7657611997-01-22SILASTIC (R) II MAMMARY IMPLANT, H.P. LPRDOWCORNDOW CORNING CORP.2200 WEST SALZBURG ROADAUBURNMI48611SERIOUS INJURYP1040320GENERAL AND PLASTIC SURGERYFTRFINALMAMMOGRAM OF 5/29/92 SHOWS NO SUSPICIOUS MASSES; HOWEVER, CLUSTERS OF CALCIFICATIONS OR ABNORMAL VASCULARITY WERE SEEN. PT HAD REMOVAL OF IMPLANTS WITH CAPSULECTOMY AND OPERATIVE REPORT SHOWS ABOUT ONE HOUR AFTER EXPLANTATION, PT DEVELOPED A HEMATOMA ON THE LEFT SIDE IN THE UPPER/OUTER PART OF THE BREAST POCKET TOWARDS THE AXILLA. THE BLEEDING WAS ENCOUNTERED AND SEVERAL SMALL AREAS WERE CAUTERIZED WHICH STOPPED THE ACTIVE BLEEDING. THE DEVICE WERE RETURNED TO CO AND UPON VISUAL EXAM THEY WERE BOTH FOUND TO BE INTACT. THE DEVICES WERE THEN RETURNED TO THE PT ON 7/16/96 WITHOUT FURTHER EVALUATION.THESE DEVICES ARE NO LONGER COMMERCIALLY AVAILABLE AND CAN ONLY BE USED UNDER CONTROLLED CLINICAL TRIALS. THESE TYPES OF EVENTS USUALLY INVOLVE KNOWN COMPLICATIONS WHICH DO NOT JUSTIFY IMMEDIATE ACTION OR REVIEW OF THE INDIVIUAL REPORT. HOWEVER, THE EVENT AND OTHER SIMILAR EVENTS ARE AVAILABLE FOR FURTHER STATISTICAL ANALYSIS AND MONITORING.
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