BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARRIER EXTRA PROTECTION SURGICAL GOWN, EXTRA LARGE

    MDR report key: 282961 · Received June 22, 2000

    Report

    Report Number
    1618732-2000-00085
    Event Type
    Other
    Date Received
    June 22, 2000
    Report Date
    June 19, 2000
    Manufacturer
    JOHNSON & JOHNSON MEDICAL
    Product Code
    FYA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SURGEON WAS PERFORMING A TOTAL KNEE ARTHROPLASTY, AND REPORTEDLY HAD THE PT'S LOWER LEG PRESSED AGAINST THE GOWN IN THE AREA OF THE STRIKE-THROUGH FOR A PROLONGED PERIOD OF TIME. THE AREA OF STRIKE-THROUGH APPEARS TO BE AT THE BOTTOM MOST AREA OF THE GOWN WHERE THE LINER ENDS. BLOOD BORNE PATHOGEN STATUS OF PT IS NOT KNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other