BEUDAMED
    FDA Adverse Event Other Summary report: N

    HA PARTICLES

    MDR report key: 67139 · Received February 7, 1997

    Report

    Report Number
    2023141-1997-00044
    Event Type
    Other
    Date Received
    February 7, 1997
    Report Date
    January 9, 1997
    Manufacturer
    CALCITEK
    Product Code
    MBE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN A LEGAL COMPLAINT, PLAINTIFF ALLEGES FOREIGN BODIES. UNK IF THE PRODUCT AS CRYSTALS WOULD NOT RESULT IN "MASSIVE METALLIC FOREIGN BODIES." INFO FROM MEDWATCH REPORT #1010472.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HA PARTICLES Implant HA PARTICLES MBE CALCITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention