BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCELL

    MDR report key: 14961006 · Received July 8, 2022

    Report

    Report Number
    3004426795-2022-00003
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    May 11, 2020
    Report Date
    August 4, 2022
    Manufacturer
    INFINITE BIOMEDICAL TECHNOLOGIES LLC
    Product Code
    IQZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MISSING INFORMATION: PATIENT INFORMATION, THE DETAILS ON PATIENT INFORMATION ARE PENDING AND WILL BE PROVIDED ONCE THE PRACTITIONER RESPONDS TO MANUFACTURER. SUSPECT MEDICAL DEVICE, 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

    THE NOTE FROM THE PROSTHETIST SAID THAT THE PATIENT REPORTED THAT THE BATTERY WAS NOT CHARGING CORRECTLY. THERE WAS NO PATIENT INJURY INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396787 FLEXCELL PROSTHETIC BATTERY SYSTEM IQZ INFINITE BIOMEDICAL TECHNOLOGIES LLC 2017200

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male ETD HAND - FILLAUER / MOTION CONTROL| OTTOBOCK ELECTRODES