BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGIANCE TRANSPARENT DRESSING

    MDR report key: 1033447 · Received April 22, 2008

    Report

    Report Number
    1836161-2008-00003
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 7, 2008
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO REMOVE TRANSPARENT DRESSING FROM PT'S ARM, THE DRESSING PEELED OFF IN SEVERAL PIECES AND WAS VERY DIFFICULT TO REMOVE FROM SKIN, CAUSING PT DISTRESS AND PAIN. IT TOOK A TOTAL OF 15 TO 20 MIN TO REMOVE THE DRESSING IN ORDER TO PREVENT A SKIN TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGIANCE TRANSPARENT DRESSING TRANSPARENT DRESSING NAD ASPEN SURGICAL PRODUCTS, INC. TD-26 2012-12-14

    Patients

    Seq Age Sex Outcome Treatment
    1