BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 11363668 · Received February 22, 2021

    Report

    Report Number
    6000034-2021-00508
    Event Type
    Injury
    Date Received
    February 22, 2021
    Report Date
    February 1, 2021
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON FEBRUARY 23, 2021.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED WOUND HEALING ISSUES WHICH WAS TREATED WITH ORAL ANTIBIOTICS. THE IMPLANT REMAINS IN-SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254087 ASKU COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention