BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE YOUTH CRUTCHES

    MDR report key: 4949662 · Received July 23, 2015

    Report

    Report Number
    MW5044857
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 23, 2015
    Product Code
    INP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    (B)(6) YEAR OLD PATIENT WITH KNEE INJURY, GIVEN CRUTCHES FOR NON-WEIGHT BEARING RIGHT KNEE. ONE CRUTCH BUCKLED WHEN THE PATIENT BEGAN TO USE THE CRUTCHES, CAUSING THE PATIENT TO FALL AND HIT HER HEAD. THE PLASTIC PIECE THAT LOCKS THE LENGTH OF THE CRUTCH LEG DOES NOT LOCK - DEFECTIVE - PULLS OFF OF CRUTCH. PATIENT DID NOT SUFFER ADDITIONAL INJURY. PATIENT GIVEN SECOND SET OF CRUTCHES. DEFECTIVE PAIR OF CRUTCHES SEQUESTERED TO BE RETURNED TO MANUFACTURER. EIGHT YEAR OLD PATIENT SUFFERED RIGHT KNEE INJURY IN A BICYCLE CRASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478033 DRIVE YOUTH CRUTCHES DRIVE YOUTH CRUTCHES INP 10431-8

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR