BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE

    MDR report key: 4241734 · Received November 10, 2014

    Report

    Report Number
    3003681312-2014-00103
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    PP930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE. THE TAMPER TUBE BECAME LODGED IN THE PATIENT REQUIRING SURGICAL REMOVAL VIA CUT DOWN. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723265 ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL PUERTO RICO, B.V. 610132

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R