BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMI WALKER, ADULT

    MDR report key: 13005555 · Received December 14, 2021

    Report

    Report Number
    1423537-2021-00700
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    November 17, 2021
    Report Date
    February 28, 2022
    Manufacturer
    JAN MAO INDUSTRIES CO. LTD.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY WHERE IT IS CURRENTLY STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT IS BEING FILED SINCE INVESTIGATION HAS BEEN COMPLETED AND DUE TO CORRECTION OF THE PRODUCT NUMBER IN SECTION D4. THE PRODUCT NUMBER ON THE ORIGINAL REPORT WAS CWAL1028HR, BUT THE CUSTOMER REPORTED THE ACTUAL PRODUCT NUMBER MATCHING THE LOT NUMBER IS CWAL1028H. BASED ON SUPPLIER INVESTIGATION, LOT NUMBER 8400012019-SH WAS SHIPPED IN MAY 2020. THE DEVICE HISTORY RECORD(DHR) REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. THE EVENT DEVICE WAS NOT RETURNED FOR INVESTIGATION. ADDITIONAL REVIEW OF THE DHR, REVEALED NO ISSUES WERE DETECTED DURING PRODUCTION AND INSPECTION. REVIEW OF THE DEVICE MASTER RECORD REVEALED THERE WAS NO CHANGE TO DESIGN, PRODUCTION PROCESS, AS WELL AS THE RELATED MATERIALS. THE FOUR RIVETS PORTION OF THE WALKER HAVE A TUBE INSERTED INSIDE OF EACH MAIN TUBE TO INCREASE THE STRENGTH OF THE FOUR RIVETS PORTION. BASED ON THE COMPLAINT DESCRIPTION, THE CUSTOMER WAS CONCERNED THE RIVETS CAME LOOSE AS THE WALKER POPPED AND CAME APART. THE SUPPLIER WAS NOT ABLE TO ASSESS WHETHER THE USER FOUND ANY SPECIFIC ABNORMAL ISSUE WITH THE WALKER, OR ANY SPECIAL REASON TO CAUSE THE REPORTED CONCERN. ACCORDING TO THE IFU WHICH MENTIONED / WARNING, ALL FOUR LEGS OF THE HEMI WALKER MUST BE ADJUSTED TO AN EQUAL HEIGHT SO THAT IT SITS LEVEL BEFORE USING. ADDITIONALLY, USER SHOULD ALSO WATCH OUT FOR POTENTIAL SAFETY HAZARDS INCLUDING SLIPPERY, UNEVEN, OR SOFT SURFACES AND OBJECTS IN THE WALKING PATH. SUPPLIER WAS NOT ABLE TO DETERMINE IF THE CUSTOMER'S REPORTED ISSUE OCCURRED BECAUSE THE HIKING TRAIL WAS UNEVEN, IMPROPER USE OF THE WALKER, OR JUST AN ACCIDENT. THE FAILURE COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED FROM THIS INVESTIGATION. THE COMPLAINT INFORMATION WAS SHARED WITH THE RELEVANT SECTORS FOR THEIR AWARENESS. THE SUPPLIER WILL CONTINUE TO MONITOR THE TRENDS FOR THIS TYPE OF INCIDENT.

    Description of Event or Problem · 0

    CONSUMER REPORTED CONCERN THAT RIVETS CAME LOOSE AS THE WALKER POPPED AND CAME APART. HE ALLEGEDLY INJURED HIMSELF WHILE USING THE HAMMY WALKER ON A HIKING TRAIL. CONSUMER REPORTEDLY TUMBLED DOWN FROM THE TRAIL AND FRACTURED HIS FINGER AND LEFT LEG AND BROKE THREE TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895049 HEMI WALKER, ADULT WALKER, MECHANICAL ITJ JAN MAO INDUSTRIES CO. LTD. CWAL1028H~TPMECC 8400012019-5H-2005

    Patients

    Seq Age Sex Outcome Treatment
    1 Male