BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 7189883 · Received January 15, 2018

    Report

    Report Number
    6000034-2018-00071
    Event Type
    Injury
    Date Received
    January 15, 2018
    Date of Event
    December 21, 2017
    Report Date
    December 21, 2017
    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
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JANUARY 15, 2018, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S ABUTMENT WAS REMOVED UNDER A GENERAL ANAESTHETIC ON (B)(6) 2017, SUBSEQUENT TO THE PATIENT EXPERIENCING SKIN OVERGROWTH AT THE ABUTMENT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35334 NI COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention