BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI300 IMPLANT 4 MM

    MDR report key: 9838330 · Received March 16, 2020

    Report

    Report Number
    6000034-2020-00712
    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
    PMA / PMN Number
    K100360
    Adverse Event
    Yes
    Report Source
    Manufacturer 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
    298140 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