BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCELL

    MDR report key: 14961014 · Received July 8, 2022

    Report

    Report Number
    3004426795-2022-00004
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Report Date
    August 25, 2022
    Manufacturer
    INFINITE BIOMEDICAL TECHNOLOGIES LLC
    Product Code
    IQZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MISSING INFORMATION: DATE OF EVENT: THE EXACT DATE OF EVENT IS UNKNOWN TO THE MANUFACTURER. MANUFACTURER RECEIVED AN EMAIL FROM THE DISTRIBUTOR REGARDING THE COMPLAINT ON (B)(6) 2020. PATIENT INFORMATION : THE BATTERY WAS TO BE USED AS A DEMO MODEL. THEREFORE, THERE ARE NO PATIENT DETAILS. SUSPECT MEDICAL DEVICE - CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: THE DETAILS ON COMPONENTS USED IN PROSTHESIS IS NOT ORESENT SINCE THE SYSTEM WAS USED FOR A DEMO MODEL.

    Additional Manufacturer Narrative · 0

    SECTION B3 - DATE OF EVENT: THE DISTRIBUTOR WAS UNABLE TO FIND THE EXACT DATE OF THE EVENT. THEREFORE, MANUFACTURER IS UNABLE TO PROVIDE THE DETAIL.

    Additional Manufacturer Narrative · 0

    SECTION B3 - DATE OF EVENT: MANUFACTURER FOLLOWED UP WITH THE DISTRIBUTOR AND IS WAITING ON THE INFORMATION FOR EXACT DATE OF THE EVENT. DISTRIBUTOR INFORMED THE MANUFACTURER THAT THE ASSIGNED PERSON IS CURRENTLY ON LEAVE AND WILL BE BACK ON AUGUST 15, 2022. INFINITE BIOMEDICAL TECHNOLOGIES LLC (IBT) WILL SEND ANOTHER FOLLOW UP REPORT ONCE THE INFORMATION IS RECEIVED FROM THE DISTRIBUTOR. PLEASE SEE THE ATTACHED EMAIL CONVERSATION WITH THE DISTRIBUTOR. "DCR2002-042 FOLLOW-UP EMAIL THREAD".

    Description of Event or Problem · 0

    EVENT: CUSTOMER REPORTED THAT DURING INSTALLATION OF ONE OF THE FLEXCELL BATTERIES THERE WAS A FLASH AND A HOLE IN THE SOCKET. IT OCCURED DURING FABRICATION OF A DEMO SOCKET. THEREFORE, NO CONSEQUENCES OR IMPACT TO PATIENT OR OTHER PERSONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396788 FLEXCELL PROSTHETIC BATTERY SYSTEM IQZ INFINITE BIOMEDICAL TECHNOLOGIES LLC 2017200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown