BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEANCUT ROTATING AORTIC PUNCH

    MDR report key: 2545220 · Received April 10, 2012

    Report

    Report Number
    1649914-2012-00004
    Event Type
    Injury
    Date Received
    April 10, 2012
    Date of Event
    February 21, 2012
    Report Date
    March 12, 2012
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REFERENCE MFG REPORT: 1649914-2012-00003. QUEST MEDICAL, INC. HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFG REPORT: 1649914-2012-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEANCUT ROTATING AORTIC PUNCH NONE DWS QUEST MEDICAL, INC. RCL45 0408811C11

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention