BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMBERLY CLARK AND ACS

    MDR report key: 496705 · Received November 14, 2003

    Report

    Report Number
    MW1030221
    Event Type
    Malfunction
    Date Received
    November 14, 2003
    Date of Event
    October 29, 2003
    Report Date
    October 31, 2003
    Manufacturer
    KIMBERLY CLARK
    Product Code
    FNY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HOLE IN WRAP AROUND BASIN, WHICH WAS NOT NOTICED UNTIL END OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY CLARK AND ACS WRAP ON BASIN WITHIN CUSTOM MINOR PACK FNY KIMBERLY CLARK * 707031

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other