BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM BTE RECHARGEABLE BATTERY, SILVER

    MDR report key: 17036259 · Received June 1, 2023

    Report

    Report Number
    6000034-2023-01784
    Event Type
    Injury
    Date Received
    June 1, 2023
    Report Date
    May 11, 2023
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON JUNE 01, 2023.

    Description of Event or Problem · 0

    PER THE CLINIC, THE RECHARGEABLE BATTERY OF THE SOUND PROCESSOR WAS FOUND TO HAVE ALLEGEDLY LEAKED FLUID. REPLACEMENT EQUIPMENT WAS SENT, AND NO REPORTS OF PATIENT INJURY ARE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296203 FREEDOM BTE RECHARGEABLE BATTERY, SILVER NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD SP12 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention