BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 8485721 · Received April 4, 2019

    Report

    Report Number
    6000034-2019-00532
    Event Type
    Injury
    Date Received
    April 4, 2019
    Report Date
    March 13, 2019
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON APRIL 05, 2019 (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AROUND THE IMPLANT SITE WHICH COULD NOT BE RESOLVED, SUBSEQUENTLY THE PATIENT WAS HOSPITALISED AND TREATED WITH IV ANTIBIOTICS. CLINICAL MANAGEMENT IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274449 ASKU COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R