BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARRIER EXTRA PROTECTION SURGICAL GOWN, LARGE

    MDR report key: 275925 · Received May 2, 2000

    Report

    Report Number
    1618732-2000-00066
    Event Type
    Other
    Date Received
    May 2, 2000
    Report Date
    April 6, 2000
    Manufacturer
    JOHNSON & JOHNSON MEDICAL
    Product Code
    FYA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SALES REPRESENTATIVE REPORTS: ACCOUNT EXPERIENCED A STRIKETHROUGH OF BLOOD ON THE SLEEVE, MID-FOREARM AREA. THERE WAS NO BLOODBORNE PATHOGEN EXPOSURE. THE DEVICE WAS DISCARDED AT THE USER FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other