BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ORTHOCOR MEDICAL

    MDR report key: 22979727 · Received September 5, 2025

    Report

    Report Number
    3008216220-2025-00001
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 7, 2025
    Report Date
    September 3, 2025
    Manufacturer
    ORTHOCOR MEDICAL
    Product Code
    ILX
    UDI-DI
    00851979007305
    PMA / PMN Number
    K241395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    USER'S FIRST BATTERY WOULD NOT STAY CHARGED; WE SENT OUT A NEW BATTERY PACK AND IT GOT HOT WHILE CHARGING. WE ARE SENDING OUT A NEW DEVICE TO HIM WITH AN EXTRA BATTERY PACK. SPOKE TO PATIENT TO MAKE SURE HE RECEIVED THE NEW DEVICE, HE LET ME KNOW THAT IT WAS HOT TO THE TOUCH AND FELT LIKE IT BURNED HIM, BUT HE HAS NO LINGERING REDNESS OR BLISTERING AND DID NOT NEED TO SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495863 ORTHOCOR MEDICAL ACTIV8 ILX ORTHOCOR MEDICAL SPC-00209 VBM050925-01 00851979007305

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male