BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACS (AMERICAN CONTRACT SYSTEMS)

    MDR report key: 490563 · Received October 3, 2003

    Report

    Report Number
    MW1029785
    Event Type
    Other
    Date Received
    October 3, 2003
    Date of Event
    September 10, 2003
    Report Date
    September 23, 2003
    Manufacturer
    ACS
    Product Code
    LRP
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN TRIED TO BREAK TAPE SEALING WRAP AROUND BASIN, IT TORE DRAPE AND PUT A HOLE IN THE WRAP. HAD TO OPEN A NEW BASIN.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 12/10/03: ACS HAS REVIEWED REPORT NUMBER MW1029712 AND MW1029785. MFR HAS PERFORMED RISK ASSESSMENTS, REVIEWED WITH THE CUSTOMER AND HAS DETERMINED NO FURTHER ACTION IS REQUIRED AT THIS TIME, BUT MFR WILL CONTINUE TO MONITOR THE SITUATION. PRODUCT HAS BEEN REPLACED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS (AMERICAN CONTRACT SYSTEMS) WRAPPED BASIN WITHIN CUSTOM MAJOR PACK LRP ACS * 770031

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other