BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 8MM

    MDR report key: 5618139 · Received April 28, 2016

    Report

    Report Number
    6000034-2016-00890
    Event Type
    Injury
    Date Received
    April 28, 2016
    Report Date
    September 9, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED, (B)(6) 2016. THE IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT UNDERWENT A PROCEDURE TO CAUTERIZE THE SKIN (DATE NOT REPORTED). CORRECTION: THE CORRECT 510(K) NUMBER IS K121317, NOT K955713 AS PREVIOUSLY REPORTED. (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN ISSUES (RED, SORE AND POSSIBLY INFECTED) AT THE ABUTMENT SITE. THE PATIENT WAS TREATED WITH TOPICAL ANTIBIOTICS AND TOPICAL STEROIDS (DATE AND DURATION NOT REPORTED. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269720 BIA400 IMPLANT 4MM W ABUTMENT 8MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93330 166640

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention