BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENASEAL CLOSURE SYSTEM-CE MARK

    MDR report key: 4957485 · Received July 31, 2015

    Report

    Report Number
    3011410703-2015-00005
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    December 5, 2014
    Report Date
    July 1, 2015
    Manufacturer
    MORRISVILLE
    Product Code
    PJQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS IS A CORRECTION TO THE INITIAL MDR WITH DATE OF THIS REPORT 01-JUL-2015. THE INITIAL MDR INCORRECTLY STATED "A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT." A REVIEW OF THE MANUFACTURING RECORDS WAS NOT PERFORMED DUE TO A LOT NUMBER NOT BEING RECEIVED FROM THE USER FACILITY.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN (B)(6). CUSTOMER REPORTED A PATIENT HAD A PLUG OF REMOVED FROM THE ENTRY SITE AFTER A VENASEAL PROCEDURE. THE CUSTOMER HAS KEPT THE PLUG AND ASKED MEDTRONIC TO FIND OUT IF IT WAS VENASEAL ADHESIVE. THE PATIENT WAS UNHARMED AND NO TREATMENT OR INTERVENTION WAS TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500549 VENASEAL CLOSURE SYSTEM-CE MARK AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MORRISVILLE SP-101 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other