BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN

    MDR report key: 2695726 · Received August 9, 2012

    Report

    Report Number
    2695726
    Event Type
    Malfunction
    Date Received
    August 9, 2012
    Date of Event
    August 8, 2012
    Report Date
    August 9, 2012
    Manufacturer
    MEDLINE
    Product Code
    IPR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ALUMINUM PUSH BUTTON ADULT MEDIUM CRUTCHES WERE NOTED TO BE CRACKED ON TOP PORTION OF CRUTCHES WHERE ARM RESTS. THE CRUTCHES WERE DISPENSED IN THE EMERGENCY ROOM AND WHEN PATIENT GOT INTO THE CAR, THE DAUGHTER RETURNED TO STATE THAT SHE NOTED THE CRACKED PIECE. ALSO IT WAS NOTED, THE CRUTCHES HAVE A VERY STRONG PLASTIC SMELL AND LEAVES THE ODOR ON THE HANDS AFTER USING.======================MANUFACTURER RESPONSE FOR ALUMINUM PUSH BUTTON ADULT MEDIUM CRUTCHES, GUARDIAN (PER SITE REPORTER).======================WE SPOKE WITH MEDLINE. WE GENERATED THE REPORT TO BE SENT TO THEIR QUALITY DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN CRUTCHES IPR MEDLINE * E120520486

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NO OTHER THERAPIES