BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCELL

    MDR report key: 14960899 · Received July 8, 2022

    Report

    Report Number
    3004426795-2022-00002
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    April 30, 2020
    Report Date
    July 8, 2022
    Manufacturer
    INFINITE BIOMEDICAL TECHNOLOGIES LLC
    Product Code
    IQZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MANUFACTURER RECEIEVED THE COMPLAINT OVER PHONE CALL. THE PROSTHETIST CALLED TO SAY THAT HE HAD A PATIENT USING FLEXCELLS, THE SYSTEM GOT VERY HOT AND STARTED SMOKING. THE PATIENT WAS ABLE TO REMOVE THE SYSTEM BEFORE HE WAS INJURED. IT WAS REPORTED THAT THE PATIENT HAD A SLIGHT BLISTER THAT DID NOT REQUIRE MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396781 FLEXCELL PROSTHETIC BATTERY SYSTEM IQZ INFINITE BIOMEDICAL TECHNOLOGIES LLC 2017200

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other OTTOBOCK QUICK DISCONNECT WRIST| PRO PLUS HAND - MOTION CONTROL| SUCTION SOCKET ELECTRODE - OTTOBOCK