BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 10193211 · Received June 24, 2020

    Report

    Report Number
    6000034-2020-01535
    Event Type
    Injury
    Date Received
    June 24, 2020
    Report Date
    June 1, 2020
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JUNE 25, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AROUND THE ABUTMENT WHICH WAS TREATED WITH A STEROID (MODE OF ADMINISTRATION UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656833 ASKU COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention