BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARRIER EXTRA PROTECTION SURGICAL GOWN

    MDR report key: 220537 · Received April 22, 1999

    Report

    Report Number
    1618732-1999-00102
    Event Type
    Other
    Date Received
    April 22, 1999
    Date of Event
    March 23, 1999
    Report Date
    March 24, 1999
    Manufacturer
    JOHNSON & JOHNSON MEDICAL
    Product Code
    FYA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ACCOUNT CONTACT REPORTS: A GENERAL SURGEON SUSTAINED STRIKETHROUGH OF FLUIDS DURING A COLON RESECTION. THE STRIKETHROUGH WAS REPORTED AS A 6-8 INCH CIRCLE AT THE THIGH LEVEL ON THE BORDER OF THE PANEL. IT IS NOT KNOWN IF THE PT HAS ANY BLOODBORNE PATHOGENIC DISEASES. THE SAMPLE WAS DISCARDED. THERE WAS NO LOT NUMBER OR PRODUCT CODE PROVIDED.

    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