BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 16850238 · Received May 1, 2023

    Report

    Report Number
    6000034-2023-01330
    Event Type
    Injury
    Date Received
    May 1, 2023
    Report Date
    May 11, 2023
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE PREVIOUS OR INITIAL MDR SUBMITTED ON MAY 02, 2023 WAS FILED INADVERTENTLY. NO GENERAL ANESTHESIA WAS USED. THIS REPORT IS SUBMITTED ON JUNE 01, 2023.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON MAY 02, 2023.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT DEVELOPED REPEATED CELLULITIS AT THE ABUTMENT SITE. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2023, IN ORDER TO REMOVE THE ABUTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711493 ASKU COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention