BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 8MM

    MDR report key: 8571749 · Received May 1, 2019

    Report

    Report Number
    6000034-2019-00640
    Event Type
    Injury
    Date Received
    May 1, 2019
    Report Date
    April 9, 2019
    Product Code
    MAH
    UDI-DI
    09321502022705
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON MAY 02, 2019. (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN ISSUES AND SUBSEQUENTLY WAS ADMINISTERED TOPICAL STEROIDS AND ORAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364220 BIA400 IMPLANT 4MM W ABUTMENT 8MM COCHLEAR BAHA CONNECT SYSTEM MAH 93330 COH1129960 09321502022705

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention