BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y-MINI CLIP TEMP STR 3 MM NARROW JAW

    MDR report key: 3981077 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16098
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    May 9, 2012
    Report Date
    May 11, 2012
    Manufacturer
    PTER LAZIC GMBH
    Product Code
    HCH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY (B)(4). (B)(4) IS THE IMPORTER OF THE DEVICE. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT "L-CLIP DID NOT COMPLETELY CLOSE OFF THE BLOOD FLOW DURING SURGERY". NO INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663304 Y-MINI CLIP TEMP STR 3 MM NARROW JAW NONE HCH PTER LAZIC GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1