BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 12038158 · Received June 21, 2021

    Report

    Report Number
    6000034-2021-01960
    Event Type
    Injury
    Date Received
    June 21, 2021
    Date of Event
    May 17, 2021
    Report Date
    February 18, 2021
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    FZE
    PMA / PMN Number
    K945154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JUNE 22, 2021.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED CHRONIC INFECTION AT THE ABUTMENT SITE, AND WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THE PATIENT WAS PLACED UNDER A GENERAL ANESTHETIC ON (B)(6) 2021, IN ORDER TO REMOVE THE ABUTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934124 ASKU COCHLEAR BAHA VISTAFIX SYSTEM FZE COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention