BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH POLYSORB 3/0 7 VIO DLU SU

    MDR report key: 3961444 · Received May 29, 2014

    Report

    Report Number
    1219930-2014-00410
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 30, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). SUPPLEMENTAL MDR# 01 SENT TO FDA ON 010/1/2014.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: WHEN THE SURGEON WAS TRYING TO SUTURE IT COULD BREAK EVEN WITHOUT TENSION. ADD'L INFO HAS BEEN REQUESTED OF THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315904 ENDO STITCH POLYSORB 3/0 7 VIO DLU SU DISPOSABLE SUTURING DEVICE GCJ COVIDIEN, FORMERLY US SURGICAL B3B0807X

    Patients

    Seq Age Sex Outcome Treatment
    1