BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 9966108 · Received April 15, 2020

    Report

    Report Number
    6000034-2020-01112
    Event Type
    Injury
    Date Received
    April 15, 2020
    Report Date
    March 27, 2020
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON APRIL 16, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED OOZING OF CLEAR LIQUID AND BLOOD FROM THE ABUTMENT SITE WHICH WAS TREATED WITH A TOPICAL ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429092 ASKU COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention