BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIM400 IMPLANT MAGNET

    MDR report key: 11009308 · Received December 15, 2020

    Report

    Report Number
    6000034-2020-03447
    Event Type
    Injury
    Date Received
    December 15, 2020
    Report Date
    November 25, 2020
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K131240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON DECEMBER 15. 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE MAGNET WAS ELECTIVELY REMOVED (DATE UNKNOWN) AND REPLACED WITH A COMPETITOR DEVICE WHICH WAS WATER PROOF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476938 BIM400 IMPLANT MAGNET COCHLEAR BAHA ATTRACT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 93550

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention