BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BA400 ABUTMENT 10MM

    MDR report key: 9838116 · Received March 16, 2020

    Report

    Report Number
    6000034-2020-00711
    Event Type
    Injury
    Date Received
    March 16, 2020
    Report Date
    February 19, 2020
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MARCH 16, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT HAD AN ABUTMENT REPLACEMENT (REASON UNKNOWN) UNDER A GENERAL ANAESTHETIC (DATE UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301328 BA400 ABUTMENT 10MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93335

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention