BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT PERCLOSE VASCULAR CLOSURE DEVICE

    MDR report key: 14788087 · Received June 22, 2022

    Report

    Report Number
    MW5110460
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    March 26, 2022
    Report Date
    June 20, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT HAS BEEN EXPERIENCING EPISODES OF UNCONSCIOUSNESS THE LAST HOURS AT A TIME CONSTANT HEADACHES INTERCRANIAL PRESSURE IRRITABILITY CONFUSION DIFFICULTY WALKING MAINTAINING BALANCE POSTURE AND AN ARRAY OF OTHER AT FIRST EFFECTS SUCH AS SWELLING IN THE NECK AND BACK AND BRUISING ON THE LOWER BACK REPORTS CONSTANT PAIN IN ALL AREAS OF THE SPINE. THE RADIOLOGIST PLACED THE ITEMS CLAIMS THAT HE NEVER DID THE PROCEDURE IN THE FIRST PLACE ALTHOUGH THE PATIENT HAS THE RECORDS AND BILLS THAT SAY OTHERWISE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090339 ABBOTT PERCLOSE VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR ON RECORDS NURSES NOTES

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Disability| R| L| O