BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CLIP 5MM CLIP APPLIER

    MDR report key: 854033 · Received May 11, 2007

    Report

    Report Number
    1219930-2007-00251
    Event Type
    Injury
    Date Received
    May 11, 2007
    Date of Event
    January 3, 2007
    Report Date
    January 17, 2007
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS RELEASED BASED ON ADD'L INFO REC'D ON 05/10/2007 AND DETERMINED TO BE MDR REPORTABLE AS A SERIOUS INJURY.

    Description of Event or Problem · 1

    PROCEDURE: UNK. REPORTEDLY, SOME METAL FRAGMENTS CAME OFF THE DEVICE AND FELL INTO THE PT CAVITY. THE FRAGMENTS WERE REMOVED WITH SOME DIFFICULTY. ADD'L INFO REC'D ON 05/10/2007 STATED SURGERY TIME WAS EXTENDED BEYOND 30 MINS DUE TO THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CLIP 5MM CLIP APPLIER CLIP APPLIER GDO NORTH HAVEN - USS N6H40

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other