BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA310 IMPLANT 4MM

    MDR report key: 10533121 · Received September 14, 2020

    Report

    Report Number
    6000034-2020-02491
    Event Type
    Injury
    Date Received
    September 14, 2020
    Report Date
    August 15, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON SEPTEMBER 15, 2020.

    Description of Event or Problem · 1

    PER THE SURGEON, THE PATIENT EXPERIENCED A SKIN INFECTION AT THE ABUTMENT SITE. THE TREATMENT OF THE INFECTION WAS NOT SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996475 BIA310 IMPLANT 4MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 92129

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention