BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARRIER BRAND EXTRA PROTECTION SURGICAL GOWN, LARGE

    MDR report key: 398846 · Received June 7, 2002

    Report

    Report Number
    2523357-2002-00002
    Event Type
    Other
    Date Received
    June 7, 2002
    Date of Event
    April 23, 2002
    Report Date
    June 7, 2002
    Manufacturer
    MOLNLYCKE HEALTH CARE, INC.
    Product Code
    FYA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE WORKING IN LABOR AND DELIVERY WAS HANDED A PATIENT. WHEN NURSE HELD THE PATIENT TO NURSE'S LEFT CHEST AND SHOULDER. NURSE EXPERIENCED STRIKETHROUGH, WHILE WEARING A BARRIER, BRAND EXTRA PROTECTION SURGICAL GOWN PC 9675. IT WAS REPORTED THAT BODY FLUIDS (SCANT AMOUNT0 PASSED THROUGH THE SCRUBS. NO KNOWN EXPOSURE TO BLOODBORNE PATHOGENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARRIER BRAND EXTRA PROTECTION SURGICAL GOWN, LARGE GOWN, SURGICAL FYA MOLNLYCKE HEALTH CARE, INC. NA 0270201

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other