BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRUTCH

    MDR report key: 17763941 · Received September 18, 2023

    Report

    Report Number
    17763941
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    August 16, 2023
    Report Date
    September 8, 2023
    Manufacturer
    MEDLINE INDUSTRIES, INC
    Product Code
    IPR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PLASTIC BRACE BROKE ON THE BOTTOM OF 2 CRUTCHES DURING PATIENT CRUTCH TRAINING. THIS CAUSED THE CRUTCHES TO SNAP/FOLD. BOTH PATIENTS WERE WELL BELOW THE CRUTCHES' WEIGHT LIMIT. MANUFACTURER RESPONSE FOR AXILLARY CRUTCH, (BRAND NOT PROVIDED) (PER SITE REPORTER). VENDOR REP MADE AWARE OF THE ISSUE AND TOOK THE CRUTCHES FOR FAILURE ANALYSIS AND PROVIDED REPLACEMENT OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303765 CRUTCH IPR MEDLINE INDUSTRIES, INC MD551514-10 15122030002

    Patients

    Seq Age Sex Outcome Treatment
    1 Male