BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN

    MDR report key: 121763 · Received September 22, 1997

    Report

    Report Number
    1618732-1997-00312
    Event Type
    Malfunction
    Date Received
    September 22, 1997
    Report Date
    August 21, 1997
    Manufacturer
    JOHNSON & JOHNSON MEDICAL, INC.
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTED THAT AN ORTHOPAEDIC SURGEON HAS REPORTED MORE THAN ONE OCCURRENCE OF STRIKETHROUGH WITH THE EXTRA PROTECTION SURGICAL GOWN, WHICH WENT TO THE SKIN. THE STRIKETHROUGH OCCURRED IN THE HIP AND THIGH AREA. NO REPORTED EXPOSURE TO BLOODBORNE PATHOGENS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN