Medical Device Reporting

$199 / year

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.

Complexity

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.

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

John Snow Labs Standard License

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

NameDescriptionTypeConstraints
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-
Access_Type_And_NumberDate_ReceivedProduct_DescriptionManufacturer_Name_CodeManufacturer_NameStreet_AddressCityStateZipcodeReport_TypeModel_NumberCatalog_NumberFDA_Panel_CodeFDA_Product_CodeEvent_Description_TypeEvent_DescriptionCloseout_Text
M1049361985-05-22TAMPAXTAMBRANDSTAMBRANDS, INCBOX 271PALMERMA1069SERIOUS INJURYOB/GYNHEBFINALALLEGED TSS.CAUSE UNKNOWN
M1049381985-05-22TAMPAXTAMBRANDSTAMBRANDS, INCBOX 271PALMERMA1069SERIOUS INJURYOB/GYNHEBFINALALLEGED TSS.CAUSE UNKNOWN
M1049391985-05-22TAMPAXTAMBRANDSTAMBRANDS, INCBOX 271PALMERMA1069SERIOUS INJURYOB/GYNHEBFINALALLEGED TSS.CAUSE UNKNOWN
M8453701994-09-07COULTER STKSCOULTERCOULTER CORP.11800 SW 147 AVEMIAMIFL33196MALFUNCTION807NAHEMATOLOGYGKZFINALCUSTOMER
M5195091994-05-13TAMPAX TAMPON, SUPERTAMBRANDSTAMBRANDS, INC.UNKUNKUN0SERIOUS INJURYNANAOB/GYNHEBPRELIMINARYALLEGED TSS.
M1028721985-03-13TAMPONTAMBRANDSTAMBRANDS INCPO BOX 271PALMERMA1069SERIOUS INJURYOB/GYNHEBFINALALLEGED TSS.CAUSE UNKNOWN
M1028731985-03-13TAMPAXTAMBRANDSTAMBRANDS INCPO BOX 271PALMERMA1069SERIOUS INJURYOB/GYNHEBFINALALLEGED TSS.CAUSE UNKNOWN
M7428881996-01-09CONDOMANSELLANSELL, INC.1500 INDUSTRIAL RD.DOTHANAL36302SERIOUS INJURYOB/GYNHISPRELIMINARYSEVERE IRRITATION.
M7508721996-03-27BUR GUARDLINVATECLINVATEC CORP.11311 CONCEPT BLVD.LARGOFL34643SERIOUS INJURYUNKUNKORTHOPEDICHXYFINALPT BURN.
M8189141995-07-20ULTIMATE TAMPONPLAYTEXPLAYTEX, INC.50 N DUPONT HWYDOVERDE19903MALFUNCTIONNANAOB/GYNHEBFINALFIBER SEPARATION.