BEUDAMED
    FDA Adverse Event Summary report: N

    EZYWRAP

    MDR report key: 538743 · Received August 4, 2004

    Report

    Report Number
    MW4003750
    Date Received
    August 4, 2004
    Date of Event
    July 8, 2004
    Report Date
    August 4, 2004
    Manufacturer
    PPI
    Product Code
    ITQ
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT RECENTLY (2004) UNDERWENT KNEE RECONSTRUCTION SURGERY. PT WAS GIVEN AN EXOTEC LEG BRACE SKU# 091521 FOR MINIMUM 6 WEEK RECOVERY. THE BRACE IS TOTALLY INFERIOR AND HAS CAUSED THEM CONTINUAL PROBLEMS AND HAS POSSIBLY EXACERBATED THEIR INJURY. IT REFUSES TO STAY IN A LOCKED POSITION AND HAS CAUSED THEM TO FALL SEVERAL TIMES FAILING TO KEEP THE LEG STRAIGHT AS THE DR HAS PRESCRIBED. PT HAS ONLY BEEN USING THE BRACE FOR APPROX 3 WEEKS AND DOES NOT FEEL THAT THE USE HAS BEEN EXCESSIVE SINCE PT WAS REQUIRED TO STAY OFF THEIR FEET FOR THE MAJORITY OF THAT THE. PT BELIEVES IT IS PPI/EXOTEC/EZYWRAP'S RESPONSIBILITY TO WARRANTY THEIR PRODUCTS AND AS SUCH PT SHOULD EITHER BE REIMBURSED FOR COST OF THE BRACE (AS PT IS REDUCED TO USING A BORROWED LEG BRACE) OR NEW -FUNCTIONING- BRACE SENT TO THEM IMMEDIATELY AT NO COST. IF NECESSARY PT CAN PROVIDE COST/PROCEDURE DOCUMENTATION TO SUPPORT THEIR CLAIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZYWRAP EXOTEC LEG BRACE ITQ PPI * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *