BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM ORTHODICS

    MDR report key: 1589589 · Received January 26, 2010

    Report

    Report Number
    MW5014533
    Event Type
    Malfunction
    Date Received
    January 26, 2010
    Date of Event
    June 1, 2007
    Report Date
    January 11, 2010
    Product Code
    KNP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    OVER THE LAST 2 1/2 YEARS, I HAVE HAD 6 PAIRS OF CUSTOM ORTHODICS, 2 FROM FOOTSOLUTIONS, 2 FROM (B) (4) AND 2 FROM ADVANCED ORTHODICS BUT PAIR HAS GOTTEN WORSE SINCE 2007. I HAVE HAD 6 PARIS OF ORTHODICS MADE. WITH ALL OF THEM, THE PAIN NEVER WENT AWAY. I WENT BACK TO EACH PLACE OF PURCHASE SEVERAL TIMES FOR ADJUSTMENTS BUT THEY STILL DID NOT SOLVE MY PROBLEMS. NONE EVER REFUNDED MY PURCHASED. I FINALLY GOT FRUSTRATED BY KEEP GOING BACK. DATES OF USE: 2007 - PRESENT. DIAGNOSIS OR REASON FOR USE: FOOT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ORTHODICS NONE KNP

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other