BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORCEPS

    MDR report key: 346534 · Received August 7, 2001

    Report

    Report Number
    MW1022623
    Event Type
    Death
    Date Received
    August 7, 2001
    Date of Event
    May 29, 1999
    Report Date
    July 31, 2001
    Manufacturer
    *
    Product Code
    HDA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    MASSIVE SUBGALEAL HEMORRHAGE IS ONE OF THE PRECIPITATING CAUSES OF PT'S DEATH. THE SUBGALEAL HEMORRHAGE AND ASSOCIATED DEATH RELATE BACK TO THE VACUUM EXTRACTOR AND FORCEPS DELIVERY. RPTR HAS HAD THE MATTER REVIEWED BY AN INDEPENDENT EXPERT WHO CONFIRMS THAT THIS DEATH IS ATTRIBUTABLE TO A VACUUM EXTRACTOR INJURY. THIS REPORT RELATES TO THE FDA PUBLIC HEALTH ADVISORY REGARDING VACUUM ASSISTED DELIVERY DEVICES DATED 5/21/98. DEATH CERTIFICATE STATES THAT PERITONITIS-BACTEREMIA, INTESTINAL PERFORATION AND MASSIVE SUBGALEAL HEMORRHAGE AND SHOCK ARE CAUSE OF DEATH. OTHER SIGNIFICANT CONDITIONS CONTRIBUTING TO DEATH: RENAL FAILURE SECONDARY TO SEVERE ACUTE TUBULAR NECROSIS SECONDARY TO SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35621 FORCEPS FORCEPS HDA * NI NI
    35730 VACUUM EXTRACTOR VACUUM EXTRACTOR HDB * NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Death 2) VACUUM EXTRACTOR 5/29/1999| 1) FORCEPS 5/29/99