BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    FLEXCELL

    MDR report key: 15479344 · Received September 24, 2022

    Report

    Report Number
    3004426795-2022-00006
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    August 8, 2022
    Report Date
    October 21, 2022
    Manufacturer
    INFINITE BIOMEDICAL TECHNOLOGIES LLC
    Product Code
    IQZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL THE REQUIRED INFORMATION HAS BEEN ADDED FOR THIS REPORT. NO INFORMATION IS CURRENTLY PENDING FROM MANUFACTURER (INFINITE BIOMEDICAL TEHNOLOGIES, LLC) .

    Additional Manufacturer Narrative · 0

    ETHNICITY: THE DETAILS ON PATIENT'S ETHNICITY WERE NOT PROVIDED BY THE PRACTITIONER, THEREFORE MANUFACTURER IS UNABLE TO PROVIDE THE DETAIL. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: COMPREHENSIVE DETAILS WERE NOT PROVIDED ON COMPONENTS USED IN PROSTHESIS. INFINITE BIOMEDICAL TECHNOLOGIES LLC IS WAITING ON ADDITIONAL INFORMATION ON CONCOMITANT DEVICES AND THAT WILL BE PROVIDED TO THE FDA ONCE THE PRACTITIONER RESPONDS TO THE MANUFACTURER (INFINITE BIOMEDICAL TECHNOLOGIES LLC).

    Description of Event or Problem · 0

    THE PROSTHETIST REPORTED THAT MARKS WERE OBSERVED ON THE JUNCTION BOX VERY CLOSE TO THE PLACE WHERE THE BATTERY PLUGS IN. DURING THE EVENT, NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435573 FLEXCELL PROSTHETIC BATTERY SYSTEM IQZ INFINITE BIOMEDICAL TECHNOLOGIES LLC 3027200

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male ETD HOOK - FILLAUER / MOTION CONTROL| OTTOBOCK ELECTRODES