BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARRIER EXTRA PROTECTION SURGICAL GOWN

    MDR report key: 42846 · Received September 27, 1996

    Report

    Report Number
    1618732-1996-00027
    Event Type
    Other
    Date Received
    September 27, 1996
    Date of Event
    August 21, 1996
    Report Date
    August 29, 1996
    Manufacturer
    JOHNSON & JOHNSON MEDICAL, INC.
    Product Code
    FYA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CESAREAN SECTION, ON 8/21/96, OF A HIGH RISK OB WITH KNOWN HEPATITIS C AND B ANTIGENS, THE SURGEON EXPERIENCED STRIKETHROUGH "MIDWAY THROUGH THE CHEST AND AT THE SIDE". REPORTED THAT THE SURGEON "USED 2 GOWNS OUT OF THE CESAREAN SECTION PACK. THE BLOOD SEEPED THROUGH TO HIS UNDERWEAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARRIER EXTRA PROTECTION SURGICAL GOWN GOWN, SURGICAL FYA JOHNSON & JOHNSON MEDICAL, INC. NA S10567

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening