BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREENS ACE KNEE STABILIZER

    MDR report key: 1298764 · Received January 28, 2009

    Report

    Report Number
    2243072-2009-00001
    Event Type
    Injury
    Date Received
    January 28, 2009
    Date of Event
    December 25, 2008
    Report Date
    January 26, 2009
    Manufacturer
    BECTON DICKINSON
    Product Code
    ITQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED. UNABLE TO RUN COMPLAINT HISTORY CHECK OR DEVICE HISTORY REVIEW AS LOT NUMBER IS UNKNOWN. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CONSUMER REPORTED WORE AN ACE KNEE STABILIZER ONE TIME AND HE GOT A LARGE RASH OF 1" HIGH AND 2" WIDE ON BACK OF HIS LEG. CONSUMER ALSO REPORTED THAT HE HAS BOILS ON OTHER PARTS OF BODY. CONSUMER DID SEE AN MD BUT NO MEDICAL TREATMENT WAS RECEIVED. A VISIT TO AN ALLERGIST WAS ALSO SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALGREENS ACE KNEE STABILIZER KNEE STABILIZER ITQ BECTON DICKINSON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other