BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 9589665 · Received January 14, 2020

    Report

    Report Number
    6000034-2020-00074
    Event Type
    Injury
    Date Received
    January 14, 2020
    Date of Event
    December 12, 2019
    Report Date
    December 30, 2019
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JANUARY 15, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH. THE ABUTMENT WAS CHANGED UNDER A GENERAL ANAESTHETIC ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48841 ASKU COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention