BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 14640918 · Received June 9, 2022

    Report

    Report Number
    6000034-2022-01671
    Event Type
    Injury
    Date Received
    June 9, 2022
    Report Date
    May 18, 2022
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED ON JUNE 09, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632068 NI COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention