BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-ANEURYSM-CLIPS

    MDR report key: 3619013 · Received February 3, 2014

    Report

    Report Number
    8010890-2013-00001
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Date of Event
    November 4, 2013
    Report Date
    November 14, 2013
    Manufacturer
    PETER LAZIC GMBH
    Product Code
    HCH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WRONG LABELING FOR L-CLIP NO. 45.222. PRODUCED IS L-CLIP NO. 45.722 - LABEL IS DOCUMENTED WITH 45.222. THE CLIPS ARTICLE NO. 45.722 AND ARTICLE NO. 45.222 ARE IN FORM IDENTICAL. THEY ARE DIFFERENT IN COLOUR AND PRESSURE. ART. NO. 45.722 HAS COLOUR PINK THAT MEANS PERMANENT WITH PRESSURE 110G. ART. NO. 45.222 HAS COLOUR PINK IN FRONT AND YELLOW IN THE BACK THAT MEANS TEMPORARY WITH PRESSURE 70G. BOTH ARE TITANIUM CLIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70584 L-ANEURYSM-CLIPS L-CLIPS MINI TITANIUM TEMPORARY HCH PETER LAZIC GMBH 45.222

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization