BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIM400 IMPLANT MAGNET

    MDR report key: 16057566 · Received December 27, 2022

    Report

    Report Number
    6000034-2022-03850
    Event Type
    Injury
    Date Received
    December 27, 2022
    Report Date
    December 2, 2022
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LBX
    PMA / PMN Number
    K131240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON DECEMBER 28, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN BREAKDOWN AND SKIN INFECTION SECONDARY TO THE EXTERNAL MAGNET BEING TOO STRONG. THE INFECTION WAS TREATED WITH TOPICAL ANTIBIOTICS. THE IMPLANT REMAINS IN-SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2653965 BIM400 IMPLANT MAGNET COCHLEAR BAHA CONNECT SYSTEM LBX COCHLEAR BONE ANCHORED SOLUTIONS AB 93550

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention