BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI300 IMPLANT 4 MM

    MDR report key: 9838114 · Received March 16, 2020

    Report

    Report Number
    6000034-2020-00713
    Event Type
    Injury
    Date Received
    March 16, 2020
    Date of Event
    August 16, 2019
    Report Date
    February 19, 2020
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MARCH 16, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN ISSUES (SPECIFICS UNKNOWN). THERE A WAS A BAHA CONNECT TO ATTRACT CONVERSION ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301326 BI300 IMPLANT 4 MM COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 92129

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention