BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI300 IMPLANT 3MM

    MDR report key: 9748421 · Received February 24, 2020

    Report

    Report Number
    6000034-2020-00543
    Event Type
    Injury
    Date Received
    February 24, 2020
    Report Date
    May 27, 2020
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K100360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION:THE INITIAL MDR SUBMITTED ON (B)(6) 2020 WAS FILED INADVERTENTLY. NO EXPLANT OR SERIOUS INJURY HAS OCCURRED. THIS REPORT IS SUBMITTED ON (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON FEBRUARY 25, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON AN UNKNOWN DATE BECAUSE "HIS BODY REJECTED THE TITANIUM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209406 BI300 IMPLANT 3MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 92128 156218

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention