BEUDAMED
    FDA Adverse Event Other Summary report: N

    EMPIRA NC RX PTCA DILATATION CATHETER

    MDR report key: 2956370 · Received February 7, 2013

    Report

    Report Number
    3004036480-2013-00001
    Event Type
    Other
    Date Received
    February 7, 2013
    Date of Event
    January 9, 2013
    Report Date
    February 7, 2013
    Manufacturer
    CREGANNA - TACTX MEDICAL
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED FOR INVESTIGATION. MANUFACTURING RECORDS WERE REVIEWED AND THERE IS NO OBJECTIVE EVIDENCE TO SUGGEST THAT THE DEVICE MAY HAVE BEEN RELEASED WITH NON-CONFORMITIES RELATED TO THE NATURE OF THIS COMPLAINT. A SERIES OF COMPLAINTS FOR THE SAME ISSUE WAS RECEIVED. ADDITIONAL SUSPECT MEDICAL DEVICES: COMPLAINT #: (B)(4), MODEL #: CE0000542, CATALOG #: SA0457-27515, EXP DATE: 12/2013; (B)(4), 75R12350N, CE0000626, SA457-35012, 12/2013; (B)(4), 75R10250N, CE0000515, SA457-25010, 11/2013; (B)(4), 75R10400N, CE0000316, SA0457-40010, 10/2013, (B)(4), 85R06200S, CE0000454, SA0456-20006, 11/2013, (B)(4), 85R20250S, CE0000470, SA0456-25020, 11/2012.

    Description of Event or Problem · 1

    (B)(6) MINISTRY OF HEALTH TESTING LAB TESTED THE PRODUCTS AFTER IMPORTATION CLEARANCE. IN THE REPORT, IT IS INDICATED THAT THERE WAS FILAMENT (A PIECE OF HAIR OF SIMILAR TISSUE) IN THE PACKAGING. THIS WAS CONCLUDED AS A NON-CONFORMITY. HAIR LIKE SUBSTANCE FOUND IN THE PACKAGE SEEN BY MAGNIFYING GLASS. PRODUCT NOT USED IN PT. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED. THE ACTUAL PRODUCT WAS NOT DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51407 EMPIRA NC RX PTCA DILATATION CATHETER LOX, CATHETER PTCA LOX CREGANNA - TACTX MEDICAL 75R15300N CE0000446

    Patients

    Seq Age Sex Outcome Treatment
    1