BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH*POLYSORB* 2/0 48 U/D DLU SU

    MDR report key: 4957335 · Received July 31, 2015

    Report

    Report Number
    9612501-2015-00447
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 21, 2015
    Report Date
    July 21, 2015
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE STITCH BROKE OFF FROM THE NEEDLE. NO BLOOD LOSS, NO TISSUE DAMAGE OR LOSS, NO EXTENDED OR TIME. NOTHING FELL INTO THE PATIENT'S CAVITY. THE PATIENT IS CURRENTLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501443 ENDO STITCH*POLYSORB* 2/0 48 U/D DLU SU SINGLE USE SUTURING DEVICE OCW COVIDIEN 170057 J4L0842X

    Patients

    Seq Age Sex Outcome Treatment
    1