BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 10681248 · Received October 14, 2020

    Report

    Report Number
    6000034-2020-02803
    Event Type
    Injury
    Date Received
    October 14, 2020
    Report Date
    September 23, 2020
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON OCTOBER 15, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LACK OF CLINICAL BENEFIT WITH DEVICE USE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED (SPECIFIC DATE NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142620 ASKU COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention