BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3008812173-2016-00035

    MDR report key: 6142190 · Received December 2, 2016

    Report

    Report Number
    3008812173-2016-00035
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 7, 2016
    Report Date
    November 8, 2016
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    MQV
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS BASED ON A CLINICAL STUDY DATA REVIEW. AT THIS POINT THE INVESTIGATION IS STILL ON GOING. A SUPPLEMENTAL MDR WILL BE COMPLETED ONCE THE INVESTIGATION IS COMPLETED. NOT RETURNED.

    Description of Event or Problem · 1

    POSSIBLY CONTACT DERMATITITS ON THE OR STAFF'S RIGHT HAND WITH ACCUFILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791674 MQV ZIMMER KNEE CREATIONS, INC. N/A KC03110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention