BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 7190076 · Received January 15, 2018

    Report

    Report Number
    6000034-2018-00073
    Event Type
    Injury
    Date Received
    January 15, 2018
    Report Date
    December 21, 2017
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JANUARY 15, 2018, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMINISTERED A CREAM, SUBSEQUENT TO THE PATIENT EXPERIENCING SCABBING AT THE ABUTMENT SITE. FOLLOWING TREATMENT, THE SITE APPEARS TO HAVE REPORTEDLY IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34960 NI COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention