BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARRIER EXTRA PROTECTION SURGICAL GOWN

    MDR report key: 239215 · Received September 3, 1999

    Report

    Report Number
    1618732-1999-00222
    Event Type
    Other
    Date Received
    September 3, 1999
    Report Date
    August 5, 1999
    Manufacturer
    JOHNSON & JOHNSON MEDICAL
    Product Code
    FYA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT CONTACT REPORTS: STRIKETHROUGH OF FLUIDS DOWN TO THE SKIN OCCURRED AROUND THE LOWER SLEEVE PORTION OF THE GOWN DURING A LIVER TRANSPLANT OPERATION. THIS WAS NOTED AFTER USE. UPON REMOVAL OF THE GOWN IT WAS NOTED THAT THE REINFORCEMENT SLEEVE PANELS WERE MISSING. THE PATIENT HAD HEPATITIS B & C. THE WEARER DID NOT HAVE ANY BREAKS IN THE SKIN AND DID NOT REQUIRE ANY FOLLOW-UP WITH EMPLOYEE HEALTH AND NO MEDICAL TREATMENT OR INTERVENTION REQUIRED. A LOT NUMBER, PRODUCT CODE OR SAMPLE WERE NOT AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other