BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARRIER ULTRA PROTECTION PLUS SURGICAL GOWN

    MDR report key: 225372 · Received May 26, 1999

    Report

    Report Number
    1618732-1999-00146
    Event Type
    Other
    Date Received
    May 26, 1999
    Report Date
    April 26, 1999
    Manufacturer
    JOHNSON & JOHNSON MEDICAL
    Product Code
    FYA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT CONTACT REPORTS: CLINICIAN EXPERIENCED STRIKETHROUGH AROUND THE CHEST, ABDOMEN, AND ARMS OF THE GOWN. THE STRIKETHROUGH OCCURRED DURING A BLOOD PROCEDURE. THERE WERE NO REPORTED BLOOD BORNE PATHOGENS INVOLVED. THE ACTUAL SAMPLE IS NOT AVAILABLE, BUT A SAMPLE FROM THE SAME LOT WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARRIER ULTRA PROTECTION PLUS SURGICAL GOWN GOWN, SURGICAL FYA JOHNSON & JOHNSON MEDICAL NA H270199F03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other