BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE FOR WALGREEN CO

    MDR report key: 2190815 · Received July 28, 2011

    Report

    Report Number
    MW5021584
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 23, 2011
    Report Date
    July 28, 2011
    Manufacturer
    WALGREEN CO.
    Product Code
    IQI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USE OF DEVICE IN ACCORDANCE WITH LABELING FOR OVER 4 HOURS ON WALKING EVENT CAUSED SEVERE BLISTERING ON CALF. PHOTOS AVAILABLE. NUMEROUS BLISTERS OVER 4 SQUARE INCHES. PERMANENT SCARRING IS PROBABLE. DRAINAGE OF BLISTERS AND TREATMENT WITH TOPICAL ANTIBIOTIC PREVENTED INFECTION. REASON FOR USE: ARTHRITIC KNEE, KNEE STABILIZATION. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACE FOR WALGREEN CO KNEE STABILIZER, LARGE IQI WALGREEN CO. 201860 34-8703-6169-7

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Disability