BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN, XL

    MDR report key: 569276 · Received January 14, 2005

    Report

    Report Number
    2523357-2005-00001
    Event Type
    Other
    Date Received
    January 14, 2005
    Date of Event
    December 3, 2004
    Report Date
    January 13, 2005
    Manufacturer
    MOLNLYCKE HEALTH CARE, AB
    Product Code
    FYE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STRIKETHROUGH IN THE ABDOMEN WHILE PERFORMING AN EXPLORATORY LAP PROCEDURE USING COPIOUS AMOUNTS OF FLUID. NO KNOWN BLOODBORNE PATHOGENS; NO ADVERSE IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN, XL GOWN, SURGICAL FYE MOLNLYCKE HEALTH CARE, AB NA P0540302F10

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other