BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI400 IMPLANT 4 MM

    MDR report key: 9584497 · Received January 13, 2020

    Report

    Report Number
    6000034-2020-00253
    Event Type
    Injury
    Date Received
    January 13, 2020
    Report Date
    October 25, 2019
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JANUARY 14, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A WOUND BREAKDOWN. A BAHA ATTRACT TO CONNECT CONVERSION WAS PERFORMED ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43294 BI400 IMPLANT 4 MM COCHLEAR BAHA ATTRACT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 93550

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention