BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK MEDICAL 4 FR MICROPUNCTURE

    MDR report key: 10082412 · Received May 21, 2020

    Report

    Report Number
    MW5094641
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    May 15, 2020
    Report Date
    May 20, 2020
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GROIN SITE - DILATOR DID BREAK OFF IN LEG AND REQUIRED SLIGHTLY LARGER INCISION, BUT WAS ABLE TO BE RETRIEVED. WILL REPORT AS PSI. DISCLOSED TO PATIENT AND HUSBAND. NO HARM TO PATIENT. SLIGHTLY LARGER INCISION. SHOULD NOT IMPEDE RECOVERY. HX OF SAH DUE TO R PCOM ANEURYSM S/P COIL EMBO ((B)(6) 2014) AND CVA DUE TO CEREBRAL VENOUS THROMBOSIS C/B SEIZURE PRESENTING TODAY FOR TREATMENT OF HER ANEURYSM RECURRENCE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541785 COOK MEDICAL 4 FR MICROPUNCTURE INTRODUCER, CATHETER DYB COOK, INC. MPIS-401-SST 13033417

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR