BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F5 CORPUS

    MDR report key: 15055042 · Received July 18, 2022

    Report

    Report Number
    MW5110943
    Event Type
    Injury
    Date Received
    July 18, 2022
    Date of Event
    July 5, 2022
    Report Date
    July 14, 2022
    Manufacturer
    PERMOBIL
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    POWERED WHEELCHAIR WITH DOCKING BRACKET CAUSED DAMAGE TO RAMP RESULTING IN THE CATASTROPHIC FAILURE OF THE RAMP WHILE THE USER WAS IN THE CHAIR AND ON THE RAMP. IT APPEARS THAT DUE TO LOW GROUND CLEARANCE, THE QLK DOCKING BRACKET/BOLT INSTALLED ON THE BOTTOM OF THE CHAIR CAUSED RIVETS WITHIN A HOME ENTRY RAMP TO SHEAR. THE CHAIR AND USER FELL, AND THE USER WAS BRIEFLY DISORIENTED, BUT SUSTAINED NO APPARENT INJURIES AT THAT TIME. HOWEVER THE USER REQUIRED ASSISTANCE IN ORDER TO GET FREE OF THE INCIDENT SITE/DEBRIS AND TO REENTER THE USER'S HOME. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668090 PERMOBIL F5 CORPUS WHEELCHAIR, POWERED ITI PERMOBIL

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Unknown Other| R ESTRADIOL | METFORMIN | SERTRALINE