BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 11874786 · Received May 25, 2021

    Report

    Report Number
    6000034-2021-01575
    Event Type
    Injury
    Date Received
    May 25, 2021
    Report Date
    May 5, 2021
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K100360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MAY 25, 2021.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH TOPICAL ANTIBIOTIC CREAM (DATE AND DURATION NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776785 ASKU COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention