BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCHLEAR BAHA CONNECT SYSTEM

    MDR report key: 5959179 · Received September 18, 2016

    Report

    Report Number
    6000034-2016-01828
    Event Type
    Injury
    Date Received
    September 18, 2016
    Report Date
    October 11, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FILED ON SEPTEMBER 19, 2016. REGISTRATION NUMBER 3009092818 EXEMPTION NUMBER E2016011. H3 OTHER TEXT : IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AT ABUTMENT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, SEPTEMBER 19, 2016.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON OCTOBER 19, 2016 BY COCHLEAR LIMITED (MANUFACTURER) ON BEHALF OF COCHLEAR AMERICAS. (B)(4). PER THE CLINIC, THE PATIENT WAS TREATED WITH TOPICAL ANTIBIOTICS FOR THE INFECTION AT THE ABUTMENT SITE (DATE AND DURATION NOT REPORTED). THE IMPLANTED DEVICE REMAINS. IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610580 COCHLEAR BAHA CONNECT SYSTEM MAH MAH COCHLEAR BONE ANCHORED SOLUTIONS AB N/A 170111

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention