BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VASCULAR PERCLOSE

    MDR report key: 8206335 · Received December 28, 2018

    Report

    Report Number
    MW5082689
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    November 1, 2018
    Report Date
    November 5, 2018
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PLASTIC THAT COVERS THE METAL PART BECAME FRACTURED. DEVICE IMMEDIATELY REMOVED WITH NO PATIENT HARM. DIAGNOSIS OR REASON FOR USE: FEMORAL ARTERY CLOSURE DEVICE FOR HEMOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044300 ABBOTT VASCULAR PERCLOSE PERCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT LABORATORIES PERCLOSE PROGLIDE 8082842

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR