BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCELL

    MDR report key: 22153187 · Received June 5, 2025

    Report

    Report Number
    3004426795-2025-00002
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    April 30, 2025
    Report Date
    June 4, 2025
    Manufacturer
    INFINITE BIOMEDICAL TECHNOLOGIES LLC
    Product Code
    IQZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 (REFERED TO AS IBT HEREAFTER), WHICH THE COMPANY MAY NOT HAVE 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

    PRACTITIONER CALLED INFINITE BIOMEDICAL TECHNOLOGIES (IBT) TO REPORT THAT ONE OF THE BATTERIES IN THE PROSTHESIS PUFFED UP AND THERE WAS SOME HEAT ASSOCIATED WITH THE INCIDENT. THE USER WAS WEARING THE PROSTHESIS AT THE TIME OF THE INCIDENT, FELT SOME PRESSURE AND WARMTH AND IMMEDIATELY TOOK THE PROSTHESIS OFF. THERE WAS NO USER INJURY INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320428 FLEXCELL PROSTHETIC BATTERY SYSTEM IQZ INFINITE BIOMEDICAL TECHNOLOGIES LLC 2017200

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female OTTOBOCK - MYOBOCK SYSTEM| OTTOBOCK - SUCTION SOCKET ELECTRODE (OB 13E202=60)| TRANSCARPAL HAND DMC PLUS