BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL F5 POWER WHEELCHAIR

    MDR report key: 17463566 · Received August 3, 2023

    Report

    Report Number
    MW5120609
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Report Date
    August 1, 2023
    Manufacturer
    PERMOBIL, INC.
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE A PERMOBIL F5 AND IT WAS UNDER WARRANTY FROM (B)(6) 2021 TO (B)(6) 2023 MY SHOCK ABSORBERS STARTED LEAKING AND HAD TO BE REPLACED THEN AGAIN IN (B)(6) 2022 THEY STARTED LEAKING AGAIN AND HAD TO BE REPLACED BUT THIS TIME PERMOBIL WOULD NOT COVER THE REPLACEMENT THEN A 3RD TIME IN (B)(6) 2023 THEY STARTED LEAKING AGAIN AND PERMOBIL WOULD NOT COVER THE REPLACEMENT EVEN THOUGH WE SHOWED A PRODUCT DEFECT IN 3 PAIRS OF SHOCKS IN 2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338953 PERMOBIL F5 POWER WHEELCHAIR WHEELCHAIR, POWERED ITI PERMOBIL, INC. F5

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male