BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BA400 ABUTMENT 12MM

    MDR report key: 12872752 · Received November 24, 2021

    Report

    Report Number
    6000034-2021-03541
    Event Type
    Injury
    Date Received
    November 24, 2021
    Report Date
    November 1, 2021
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer 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
    1768837 BA400 ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93336

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention