BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BA400 ABUTMENT 12MM

    MDR report key: 12872756 · Received November 24, 2021

    Report

    Report Number
    6000034-2021-03542
    Event Type
    Injury
    Date Received
    November 24, 2021
    Report Date
    November 1, 2021
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON NOV 25, 2021.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED WOUND HEALING ISSUES AND PERSISTENT INFECTIONS THAT WERE TREATED WITH VARIOUS TOPICAL TREATMENTS AND ORAL ANTIBIOTICS. THE IMPLANT REMAINS IN-SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768838 BA400 ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93336

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention