BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADULT CRUTCHES

    MDR report key: 4208933 · Received October 21, 2014

    Report

    Report Number
    2428983-2014-00002
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    July 1, 2014
    Report Date
    October 21, 2014
    Manufacturer
    BLISS HEALTH PRODUCTS CO., LTD.
    Product Code
    IPR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLAIMANT RETURNED THE PRODUCT TO A AND M PHARMACY AND SURGICAL SUPPLIES FOLLOWING THE ALLEGED INCIDENT. ON (B)(6) 2014 A AND E PHARMACY (DAPESH) STATED THE HANDGRIP BOLT AND WING NUT WERE NOT RETURNED AND THEY NEEDED AUTHORIZATION FROM KINRAY (PHARMACY SUPPLIER) TO RETURN THE CRUTCHES TO GF HEALTH PRODUCTS, INC. FOR EVALUATION. TODAY, 10/21/2014, THE PHARMACY STATED THE CRUTCHES WERE THROWN AWAY. HANG TAG ATTACHED TO CRUTCHES: SAFETY GUIDELINES - PLEASE READ BEFORE USE. WARNING: WING NUTS MUST BE TIGHT AT ALL TIMES. WARNING: IF COMPONENTS ARE DAMAGED OR MISSING, CONTACT YOUR DISTRIBUTOR IMMEDIATELY.

    Description of Event or Problem · 1

    CLAIMANT STATES THAT SHE WAS WALKING ON THE SIDEWALK USING HER CRUTCHES WHEN ONE OF THE CRUTCHES FELL APART AT THE HAND GRIP CAUSING HER TO FALL. SHE ALLEGES THE RECENTLY INSERTED PINS IN FOUR SMALL TOES (LEFT FOOT) WERE BENT. SHE ANTICIPATES HAVING THE PINS REPAIRED IN (B)(6) 2015 WHEN THE WEATHER PERMITS. SHE STATED THE CRUTCHES WERE PURCHASED AT A PHARMACY THE DAY BEFORE THE INCIDENT WRAPPED IN PLASTIC. HER SURGEON FITTED THE CRUTCHES PRIOR TO HER USE. NO MEDICAL SUBSTANTIATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669119 ADULT CRUTCHES IPR BLISS HEALTH PRODUCTS CO., LTD. 3610LF-8 BMP217MO

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention