BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL JOINT CUSTOM PACK

    MDR report key: 398346 · Received June 4, 2002

    Report

    Report Number
    MW1025235
    Event Type
    Injury
    Date Received
    June 4, 2002
    Date of Event
    May 16, 2002
    Report Date
    June 4, 2002
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/7/02: CARDINAL HEALTH (ALLEGIANCE HEALTHCARE) WAS NOTIFIED OF THIS EVENT ON MAY 24, 2002. INVESTIGATION REVEALED THAT THE DRAPE REINFORCEMENT HAS PASSED THE PRIMARY SKIN TOXICITY IRRITATION TEST. THEREFORE, IT IS UNLIKELY THAT PT SAFETY COULD BE AFFECTED WITH RECURRENCE OF THE EVENT. THE EXACT ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    WHEN USING TOTAL JOINT CUSTOM PACK THE DRAPES WERE BLEEDING BLUE DYE ON THE PT'S SKIN AFTER IT WAS SATURATED WITH FLUID. THE BLUE WAS REMOVED FROM THE PT'S SKIN WITH SOAP AND WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL JOINT CUSTOM PACK CUSTOM PACK KKX ALLEGIANCE HEALTHCARE CORP * 533619

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention