BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 12215411 · Received July 22, 2021

    Report

    Report Number
    6000034-2021-02175
    Event Type
    Injury
    Date Received
    July 22, 2021
    Date of Event
    April 20, 2021
    Report Date
    July 1, 2021
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JUL 23, 2021.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION OF THE IMPLANT SECONDARY TO AN INFECTION. A NEW DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105768 ASKU COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention