BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARRIER EXTRA PROTECTION SURGICAL GOWN, LARGE

    MDR report key: 231885 · Received July 14, 1999

    Report

    Report Number
    1618732-1999-00203
    Event Type
    Other
    Date Received
    July 14, 1999
    Report Date
    June 25, 1999
    Manufacturer
    JOHNSON & JOHNSON MEDICAL
    Product Code
    FYA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ACCOUNT CONTACT REPORTS: CLINICIAN EXPERIENCED STRIKETHROUGH OF FLUIDS BELOW THE BREAST AREA ON THE GOWN. THE BLOOD WENT THROUGH TO THE UNDERSHIRT. THE PROCEDURE WAS A TOTAL HIP REPLACEMENT. THERE WERE NO KNOWN BLOODBORNE PATHOGENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARRIER EXTRA PROTECTION SURGICAL GOWN, LARGE GOWN, SURGICAL FYA JOHNSON & JOHNSON MEDICAL NA H100399F03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other