BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PPE GOWNS

    MDR report key: 19939537 · Received August 7, 2024

    Report

    Report Number
    MW5158153
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Report Date
    August 4, 2024
    Manufacturer
    UNKNOWN
    Product Code
    OEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    POTENTIAL CROSS CONTAMINATION USING OUR COHESIVE BANDAGES ON MULTIPLE DONORS AFTER TAKING THE NEEDLE OUT AND WRAPPING THEM WITH THE USED BANDAGES. WE SHOULD BE USING ONE PER DONOR TO AVOID CROSS CONTAMINATION. ADDITIONALLY, WE SHOULD BE CHANGING 1 GOWN PERSONAL PROTECTION EQUIPMENT (PPE) PER STAFF MEMBER PER DAY AS WE DEAL WITH BLOOD, BUT WE ARE NOW TO RESTRICT OUR GOWNS/PPE TO 2 GOWNS PER STAFF MEMBER PER WEEK. OUR GOWNS ARE CONTAMINATED WITH BLOOD. REFERENCE REPORT: MW5158152.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2265659 PPE GOWNS NON-SURGICAL GOWN OEA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown