BEUDAMED
    FDA Adverse Event Death Summary report: N

    EASY RISE WALKER

    MDR report key: 13176762 · Received January 5, 2022

    Report

    Report Number
    MW5106483
    Event Type
    Death
    Date Received
    January 5, 2022
    Date of Event
    November 12, 2021
    Report Date
    January 4, 2022
    Manufacturer
    UNK
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CONCUSSION, HEAD LACERATION. THE PRODUCT WAS PURCHASED FOR THE SIT STAND OPTION FOR MY BROTHER (B)(6) YEARS OLD BY MY MOTHER FROM (B)(6) COMPANY IN (B)(6). WALKER NUMBER (B)(4). THE WALKER WAS REMOVED FROM BOX AND OPENED PER INSTRUCTIONS HOWEVER WHEN MY BROTHER TRIED TO TURN WALKER TO FACE DIRECTION HE WISHED TO GO THE TOP TWISTED ON HIM CAUSING HIM TO LOSE HIS BALANCE AND FALL TO GROUND. COMPANY OFFERED A (B)(6) GIFT VOUCHER AND ASKED US TO RETURN WALKER. I DID NOT FOR FEAR IT WOULD NOT BE REPORTED AS A HAZARDOUS DEVICE. WHICH I FEEL HASTENED MY BROTHERS DEATH FROM THE HEAD INJURY HE SUSTAINED. PLEASE REVIEW PRODUCT FOR SAFETY AND RECALL. THANK YOU. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2477163 EASY RISE WALKER WALKER, MECHANICAL ITJ UNK 354773

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other| D