BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIZARD H

    MDR report key: 93780 · Received May 22, 1997

    Report

    Report Number
    1217435-1997-00167
    Event Type
    Malfunction
    Date Received
    May 22, 1997
    Date of Event
    April 9, 1997
    Report Date
    April 25, 1997
    Manufacturer
    USCI DIV C.R. BARD, INC.
    Product Code
    MAV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE MANOMETER OF THIS DEVICE WAS DEFECTIVE. REPORTEDLY, THE MANOMETER REGISTERED A 2 BAR PRESSURE INSTEAD OF ZERO PRESSURE. THE DEVICE WAS REMOVED AND REPLACED. THERE IS NO REPORT OF PT INJURY. THE DEVICE BEING RETURNED FOR CO'S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIZARD H INFLATION DEVICE MAV USCI DIV C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN