BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL VIP

    MDR report key: 6740074 · Received July 25, 2017

    Report

    Report Number
    6740074
    Event Type
    Malfunction
    Date Received
    July 25, 2017
    Date of Event
    June 16, 2017
    Report Date
    July 5, 2017
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LOSS OF RIGHT PEDAL PULSES. LOSS OF PULSE POST CEREBRAL ANGIOGRAM. COMMENT: SURGERY ON RIGHT LEG DESCRIPTION: LOSS OF RIGHT PEDAL PULSES. ANGIO-SEAL VIP. ST. JUDE MEDICAL INC. REF 610131, LOT 5914476.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520242 ANGIO-SEAL VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL 5914476

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other