BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVA BL 1X60 T-60/GS-26 01

    MDR report key: 3231876 · Received July 10, 2013

    Report

    Report Number
    9612501-2013-00076
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 14, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER: (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROTOMY. ACCORDING TO THE REPORTER: WHILE IN PACU THERE WAS WOUND DEHISCENCE AND EVISCERATION. ON RE-EXPLORATION, THE SUTURES WERE BROKEN. THE SUTURES WERE NOT UNTIED OR MIGRATED THROUGH THE FASCIA. THE PRODUCT WAS REMOVED AND ANOTHER WAS PLACED WITHOUT ANY COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315103 NOVA BL 1X60 T-60/GS-26 01 NOVAFIL GAR COVIDIEN D0C0216

    Patients

    Seq Age Sex Outcome Treatment
    1 Other