BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARRIER EXTRA PROTECTION SURGICAL GOWN, EXTRA LARGE

    MDR report key: 493328 · Received October 30, 2003

    Report

    Report Number
    2523357-2003-00007
    Event Type
    Other
    Date Received
    October 30, 2003
    Date of Event
    July 31, 2003
    Report Date
    October 30, 2003
    Manufacturer
    MOLNLYCKE HEALTH CARE AB
    Product Code
    FYE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SCRUB NURSE REPORTED EXPERIENCING "STRIKETHROUGH" IN THE LEG AREA OF THE GOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARRIER EXTRA PROTECTION SURGICAL GOWN, EXTRA LARGE GOWN, SURGICAL FYE MOLNLYCKE HEALTH CARE AB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other