BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 22044052 · Received May 19, 2025

    Report

    Report Number
    6000034-2025-01731
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    April 4, 2025
    Report Date
    June 19, 2025
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE PREVIOUS AND INITIAL MDR SUBMITTED ON MAY 27, 2025, AND MAY 19, 2025, RESPECTIVELY WERE FILED INADVERTENTLY. THE CORRECT INITIAL DATE OF AWARENESS IS APRIL 22, 2025.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE PREVIOUS OR INITIAL MDR SUBMITTED ON MAY 19, 2025, WAS FILED INADVERTENTLY. THE CORRECT INITIAL DATE OF AWARENESS IS 11 MAR 2025.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF FIXTURE SUBSEQUENT TO A FALL ON (B)(6) 2025. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050549 NI COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Female Required Intervention