BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCHLEAR BAHA ATTACT SYSTEM

    MDR report key: 5750281 · Received June 26, 2016

    Report

    Report Number
    6000034-2016-01271
    Event Type
    Injury
    Date Received
    June 26, 2016
    Report Date
    August 15, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K131240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    THE CORRECT BRAND NAME IS COCHLEAR BAHA ATTRACT SYSTEM, NOT FLANGE FIXTURE AND ABUTMENT AS PREVIOUSLY REPORTED. THE CORRECT 510(K) CODE IS K131240, NOT K955713 AS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CLINIC, THE PATIENT WAS TREATED WITH PICC LINE AND IV ANTIBIOTICS (DATE AND DURATION NOT REPORTED) FOR THE RECURRENT INFECTIONS AT THE IMPLANT SITE.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPEREINCED RECURRENT INFECTIONS AND WAS SUBSEQUENTLY TREATED WITH ORAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404392 COCHLEAR BAHA ATTACT SYSTEM LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 93882

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention