BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC PUNCH

    MDR report key: 899037 · Received July 19, 2007

    Report

    Report Number
    899037
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Date of Event
    January 2, 2007
    Report Date
    July 19, 2007
    Manufacturer
    PORTER MEDICAL PRODUCTS, INC.
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN USING THE AORTIC PUNCH, THERE WAS DAMAGE TO THE AORTA THAT WAS ABLE TO BE REPAIRED WITHOUT HARM TO THE PATIENT; HOWEVER, DOCTOR FEELS PUNCH IS INFERIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AORTIC PUNCH AORTIC PUNCH DWS PORTER MEDICAL PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR