BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L-CLIP APPL/REMVR 90 MM RND HANDLE VAR

    MDR report key: 3994543 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-15520
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    June 26, 2012
    Report Date
    July 6, 2012
    Manufacturer
    PETER LAZIC GMBH
    Product Code
    HCI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT DURING AN ANEURYSM CLIPPING PROCEDURE, THE DEVICE WOULD NOT RELEASE THE ANEURYSM CLIP. THE VESSEL WAS RUPTURED AND THE PT IS RECOVERY. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663057 L-CLIP APPL/REMVR 90 MM RND HANDLE VAR NONE HCI PETER LAZIC GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R