BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCELL

    MDR report key: 20912885 · Received December 12, 2024

    Report

    Report Number
    3004426795-2024-00001
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 14, 2024
    Report Date
    January 9, 2025
    Manufacturer
    INFINITE BIOMEDICAL TECHNOLOGY, LLC
    Product Code
    IQZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFINITE BIOMEDICAL TECHNOLOGIES IS SUBMITTING THE INFORMATION TO COMPLY BY 21 CFR 803. THIS REPORT IS BASED ON THE INFORMATION RECEIVED BY INFINITE BIOMEDICAL TECHNOLOGIES LLC (REFFERED TO AS IBT HEREAFTER), WHICH THE COMPANY MAY HAVE NOT BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. IBT HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. NOTE: H4: DEVICE MANUFACTURER DATE: THE DEVICE MANUFACTURING DATE ADDED IS BASED ON THE INFORMATION AVAILABLE WITH THE MANUFACTURER FROM THE TIME WHEN THE FLEXCELL KIT WAS SOLD AND SHIPPED. FOLLOWING ARE THE SECTIONS THAT IBT IS CURRENTLY WORKING ON TO OBTAIN MORE INFORMATION ON: A5: ETHNICITY.

    Additional Manufacturer Narrative · 0

    INFINITE BIOMEDICAL TECHNOLOGIES IS SUBMITTING THE INFORMATION TO COMPLY BY 21 CFR 803. THIS REPORT IS BASED ON THE INFORMATION RECEIVED BY INFINITE BIOMEDICAL TECHNOLOGIES LLC (REFEREED TO AS IBT HEREAFTER), WHICH THE COMPANY MAY HAVE NOT BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. IBT HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT.

    Description of Event or Problem · 0

    EVENT: PROSTHETIST REPORTED THAT PATIENT WAS DRIVING TO THE PROSTHETISTS OFFICE, AND THE PROSTHESIS WAS PUT ON CHARGING VIA CAR CHARGER IN THE SEAT NEXT TO HIM. ABOUT 10 MINUTES LATER, THE PATIENT SMELLED SMOKE AND DISCONNECTED THE CHARGER. THE PROSTHESIS WAS DISASSEMBLED AT THE CLINIC, AND WAS OBSERVED THAT 1 OF THE 4 BATTERIES WERE DAMAGED. THERE WAS NO PATIENT INJURY INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203984 FLEXCELL PROSTHETIC BATTERY SYSTEM IQZ INFINITE BIOMEDICAL TECHNOLOGY, LLC 2017200

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male ETD HOOK| MOTION CONTROL PRO-WRIST| OTTOBOCK SUCTION ELECTRODES