BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 11963705 · Received June 9, 2021

    Report

    Report Number
    6000034-2021-01658
    Event Type
    Injury
    Date Received
    June 9, 2021
    Report Date
    May 17, 2021
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    FZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS EXPERIENCED CONTINUED SKIN OVERGROWTH AT THE ABUTMENT SITE. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA (DATE NOT REPORTED) IN ORDER TO REMOVE THE ABUTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861926 ASKU COCHLEAR BAHA VISTAFIX SYSTEM FZE COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention