BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCELL MINI

    MDR report key: 15295457 · Received August 25, 2022

    Report

    Report Number
    3004426795-2022-00005
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Report Date
    October 21, 2022
    Manufacturer
    INFINITE BIOMEDICAL TECHNOLOGIES LLC
    Product Code
    IQZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DETAILS ON PATIENT INFORMATION ARE PENDING AND WILL BE PROVIDED ONCE THE PRACTITIONER RESPONDS TO MANUFACTURER. DATE OF EVENT: - THE EXACT DATE OF THE EVENT IS NOT KNOWN AND THE CLINICIAN INFORMED THE MANUFACTURER THAT THEY CAN'T DIG UP THE DATE OF EVENT. THEREFORE, MANUFACTURER (IBT) IS UNABLE TO PROVIDE THE DATE OF THE EVENT. RELEVANT TESTS/LABORATORY DATA: THE PARTS WERE DISPOSED BY THE CLINICIAN. THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED ON THE AFFECTED PARTS. 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. IF REMEDIAL ACTION INITIATED: NO REMEDIAL ACTION HAS BEEN TAKEN BY THE MANUFACTURER AS THE CLINICIAN IS NOT VERY RESPONSIVE.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER (INFINITE BIOMEDICAL TECHNOLOGIES LLC, HERE AFTER REFERRED TO AS IBT) TRIED TO REACHING OUT TO THE CLINICIAN BUT HE IS NOT VERY RESPONSIVE. IBT HAS SETUP A MEETING WITH THE DISTRIBUTORS TO GAIN MORE INFORMATION ON THIS ISSUE. A FOLLOW-UP REPORT WILL BE SENT BASED ON THE INFORMATION OBTAINED FROM THE DISTRIBUTOR.

    Additional Manufacturer Narrative · 0

    INFINITE BIOMEDICAL TECHNOLOGIES (HEREAFTER REFERRED TO AS IBT) REACHED OUT TO THE DISTRIBUTOR TO OBTAIN MORE INFORMATION ON THIS ISSUE. IBT HAD REQUESTED FOLLOWING INFORMATION 1. SECTION A: PATIENT INFORMATION. 2. SECTION B3: DATE OF EVENT. 3. SECTION D - SUSPECT MEDICAL DEVICE, BLOCK 10 - CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES WILL NOT BE PROVIDED DUE TO CONFIDENTIALITY RULES AT THE HOSPITAL. DISTRIBUTOR INFORMED THAT THE ABOVE REQUESTED INFORMATION CANNOT BE PROVIDED DUE TO CONFIDENTIALITY RULES AT THE HOSPITAL. THEREFORE IBT CANNOT PROVIDE ANY FURTHER DETAIL ON THIS REPORT.

    Description of Event or Problem · 0

    PATIENT'S PROSTHESIS STOPPED WORKING AND HAD A BURNT SMELL. WHEN OPENED, IT WAS OBSERVED THAT THE COMPONENTS NEAR THE FLEXCELL SYSTEM WERE DAMAGED. DURING THE EVENT, NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2101067 FLEXCELL MINI PROSTHETIC BATTERY SYSTEM IQZ INFINITE BIOMEDICAL TECHNOLOGIES LLC 3027200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown