BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI400 IMPLANT 4 MM

    MDR report key: 9584495 · Received January 13, 2020

    Report

    Report Number
    6000034-2020-00252
    Event Type
    Injury
    Date Received
    January 13, 2020
    Report Date
    October 25, 2019
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K131240
    Adverse Event
    Yes
    Report Source
    Manufacturer 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
    43289 BI400 IMPLANT 4 MM COCHLEAR BAHA ATTRACT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 93550

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention