BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 7453367 · Received April 24, 2018

    Report

    Report Number
    6000034-2018-00832
    Event Type
    Injury
    Date Received
    April 24, 2018
    Report Date
    April 4, 2018
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON APRIL 24, 2018, (B)(4).

    Description of Event or Problem · 1

    PER THE SURGEON, THE PATIENT EXPERIENCED SOFT TISSUE COMPLICATIONS AT THE ABUTMENT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, APRIL 24, 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296245 ASKU COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention