BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCELL

    MDR report key: 14960964 · Received July 8, 2022

    Report

    Report Number
    3004426795-2022-00001
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    April 22, 2020
    Report Date
    August 4, 2022
    Manufacturer
    INFINITE BIOMEDICAL TECHNOLOGIES LLC
    Product Code
    IQZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DETAILS ON PATIENT INFORMATION ARE PENDING AND WILL BE PROVIDED ONCE THE PRACTITIONER RESPONDS TO MANUFACTURER. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: THE DETAILS ON COMPONENTS USED IN PROSTHESIS ARE PENDING AND WILL BE PROVIDED ONCE THE PRACTITIONER RESPONDS TO THE MANUFACTURER.

    Description of Event or Problem · 0

    ACCORDING TO THE PROSTHETIST, THE BATTERY HAD BEEN FULLY CHARGED AND WAS IN USE WHEN IT SUDDENLY STOPPED WORKING. THE PATIENT ATTEMPTED TO JUMP IT OR REBOOT IT WITHOUT SUCCESS. THE PATIENT THEN PLUGGED THE SOCKET INTO THE CAR CHARGER. IT WAS EXTREMELY HOT AND SMELLED LIKE IT WAS MELTING WHILE UNPLUGGING THE CAR CHARGER. THE PATIENT ATTEMPTED TO CHARGE THE SOCKET AGAIN AT HOME WITH NO SUCCESS. DURING THE EVENT, NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396785 FLEXCELL PROSTHETIC BATTERY SYSTEM IQZ INFINITE BIOMEDICAL TECHNOLOGIES LLC 2017200

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male ELECTRIC WRIST ROTATOR - OTTOBOCK| ETD HAND - FILLAUER / MOTION CONTROL| FILLAUER MOTION CONTROL ETD HOOK| LAMINATION RING - OTTOBOCK| MYOTRONIC - OTTOBOCK| SUCTION SOCKET ELECTRODES - OTTOBOCK| TASKA HAND - TASKA