BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN CRUTCH

    MDR report key: 23122315 · Received September 22, 2025

    Report

    Report Number
    MW5176353
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    September 16, 2025
    Report Date
    September 17, 2025
    Manufacturer
    MEDLINE / / MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    IPR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DEFECTIVE CRUTCHES ISSUED BY (B)(6) ON (B)(6) 2025. THE RUBBER TIPS WORE DOWN WITHIN DAYS, EXPOSING THE METAL UNDERNEATH. ONCE THE METAL WAS EXPOSED, THE CRUTCH LOST TRACTION. ADVERSE EVENT: ON (B)(6) 2025, WHILE USING THE CRUTCHES AT HOME, THE EXPOSED METAL TIP SLIPPED SUDDENLY, CAUSING ME TO FALL. I SUSTAINED A SECONDARY INJURY TO MY RECENTLY OPERATED LEG (TIBIA SURGERY PERFORMED (B)(6) 2025 BY DR. (B)(6)). ADDITIONAL NOTES: I HAD RECEIVED PT INSTRUCTIONS ON PROPER CRUTCH USE PRIOR TO DISCHARGE. THE CRUTCHES FAILED AFTER ONLY MINIMAL USE AND POSED A SERIOUS SAFETY RISK. PHOTOGRAPHS OF THE WORN RUBBER TIPS ARE AVAILABLE. OUTCOME: SECONDARY INJURY REQUIRING ADDITIONAL MEDICAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201130 GUARDIAN CRUTCH CRUTCH IPR MEDLINE / / MEDLINE INDUSTRIES, LP - NORTHFIELD 88525020002

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Disability| R| O TYLENOL