BEUDAMED
    FDA Adverse Event Summary report: N

    CRUTCH

    MDR report key: 3011878 · Received March 19, 2013

    Report

    Report Number
    1531186-2013-01144
    Date Received
    March 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    HEALTHPLUS
    Product Code
    IPR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). INJURY ALLEGED. MALFUNCTION ALLEGED. PER DEALER, THE CRUTCH BROKE IN HALF WHILE THE CONSUMER WAS USING IT. ALLEGEDLY, THIS CAUSED THE END USER TO FALL AND PUT PRESSURE ON A FOOT THAT SHE JUST HAD SURGERY ON, POSSIBLY TEARING HER ACHILLES TENDON. MEDICAL INTERVENTION SOUGHT. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113592 CRUTCH 890.3150 IPR HEALTHPLUS 8115-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other