BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARRIER BRAND ULTRA PROTECTION SURGICAL GOWN, LARGE

    MDR report key: 409965 · Received August 9, 2002

    Report

    Report Number
    2523357-2002-00003
    Event Type
    Other
    Date Received
    August 9, 2002
    Date of Event
    July 1, 2002
    Report Date
    August 9, 2002
    Manufacturer
    MOLNLYCKE HEALTH CARE, INC.
    Product Code
    FYE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE NURSE IN CHARGE REPORTED THAT THE DOCTOR WAS PERFORMING A NEWBORN DELIVERY AND WHILE WEARING A BARRIER BRAND ULTRA PROTECTION SURGICAL GOWN PC 0579, THE DOCTOR'S SCRUB TOP, T-SHIRT AND PANT BOTTOM BECAME WET FROM THE FLUIDS OF THE PROCEDURE. NO BLOODBORN PATHOGEN EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARRIER BRAND ULTRA PROTECTION SURGICAL GOWN, LARGE GOWN, SURGICAL FYE MOLNLYCKE HEALTH CARE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other