BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI300 IMPLANT 3MM

    MDR report key: 9748423 · Received February 24, 2020

    Report

    Report Number
    6000034-2020-00544
    Event Type
    Injury
    Date Received
    February 24, 2020
    Report Date
    May 27, 2020
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON (B)(6) 2020.

    Description of Event or Problem · 0

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

    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
    209407 BI300 IMPLANT 3MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 92128 156218

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention