BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUELLER SPORT CARE ANKLE SUPPORT

    MDR report key: 1386562 · Received May 15, 2009

    Report

    Report Number
    MW5011111
    Event Type
    Malfunction
    Date Received
    May 15, 2009
    Date of Event
    April 8, 2009
    Report Date
    May 5, 2009
    Manufacturer
    MUELLER SPORTS MEDICINE, INC.
    Product Code
    ITW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE DEVICE (ANKLE SUPPORT) WAS TIGHT AND CAUSED HIGH DEGREE OF DISCOMFORT WHILE WEARING IT. I BOUGHT SIZE LARGE WHICH THE PACKAGING STATED WAS FOR MEN'S SHOE SIZE 11-13. I WEAR SIZE 10 1/2 SHOE. THE PRODUCT WAS TIGHT AND CONSTRICTIVE ON THE ANKLE. THE PRODUCT INFORMATION ON THE BOX STATED THAT LARGE WAS FOR MEN SHOE SIZE 11-13. I WEAR SIZE 10 1/2. ALSO WHILE PUTTING ON THE PRODUCT THERE WAS A RIPPING SOUND AND UPON EXAMINATION THE PRODUCT WAS RIPPED. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: ANKLE PAIN. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MUELLER SPORT CARE ANKLE SUPPORT ANKLE SUPPORT ITW MUELLER SPORTS MEDICINE, INC. 6503 2908

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR