BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 8762940 · Received July 4, 2019

    Report

    Report Number
    6000034-2019-01258
    Event Type
    Injury
    Date Received
    July 4, 2019
    Report Date
    June 18, 2019
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JULY 05, 2019.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT ABUTMENT SITE; SUBSEQUENTLY THE PATIENT UNDERWENT SKIN REVISION SURGERY AND WAS ADMINISTERED A TOPICAL ANTIBIOTIC (DATE NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556378 NI COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention