BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDUSA MULTI-COIL

    MDR report key: 5405480 · Received February 2, 2016

    Report

    Report Number
    3009688825-2016-00001
    Event Type
    Injury
    Date Received
    February 2, 2016
    Date of Event
    December 10, 2015
    Report Date
    February 1, 2016
    Manufacturer
    ENDOSHAPE, INC.
    Product Code
    KRD
    UDI-DI
    10857798005017
    PMA / PMN Number
    K140796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IMPLANTED SUCCESSFULLY. NO PROBLEM REPORTED WITH USE OF DEVICE. DEEP VEIN THROMBOSIS IS A KNOWN RISK WITH VENOUS EMBOLIZATION. DEVICE WAS NOT EXPLANTED.

    Description of Event or Problem · 1

    PATIENT TREATED WITH MMC-122 EMBOLIZATION DEVICE FOR VENOUS INSUFFICIENCY ON (B)(6) 2015. DEEP VEIN THROMBOSIS DIAGNOSED ON (B)(6) 2015. PATIENT GIVEN WARFARIN AND FOLLOWED FOR TWO WEEKS. NO PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62956 MEDUSA MULTI-COIL VASCULAR EMBOLIZATION DEVICE KRD ENDOSHAPE, INC. MMC-122 1003804 10857798005017

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention