BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXIBLE BIOPSY FORCEPS-ELONGTED CUP

    MDR report key: 10176 · Received September 4, 1993

    Report

    Report Number
    10176
    Event Type
    Death
    Date Received
    September 4, 1993
    Date of Event
    August 23, 1993
    Report Date
    September 2, 1993
    Manufacturer
    COOK
    Product Code
    DWZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN CARDIAC CATH LAB UNDERGOING MULTIPLE BIOPSIES OF THE MYOCARDIUM. SUDDENLY BECAME HYPOTENSIVE AND DEVELOPED CARDIAC TAMPONADE. PERICARDIOCENTESIS DONE TO EVACUATE EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIBLE BIOPSY FORCEPS-ELONGTED CUP BIOPSY FORCEPS DWZ COOK 424153

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Death