BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 8820150 · Received July 24, 2019

    Report

    Report Number
    6000034-2019-01334
    Event Type
    Injury
    Date Received
    July 24, 2019
    Report Date
    July 9, 2019
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JULY 24, 2019, BY COCHLEAR LTD.

    Description of Event or Problem · 1

    RECIPIENT REPORTED THAT HER ABUTMENT FELL OUT IN YEAR 2018 (DATE ON REPORTED) DUE TO A CHRONIC INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, JULY 24, 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615063 NI COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention