BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL

    MDR report key: 2082622 · Received May 2, 2011

    Report

    Report Number
    2082622
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 23, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CLOSURE OF THE UTERUS WAS PERFORMED, THE FIRST LAYER WAS CLOSED WITH A RUNNING LOCKING SUTURE OF 0 VICRYL FROM BOTH ENDS TIED IN THE MIDLINE. THE SECOND LAYER WAS CLOSED WITH A RUNNING IMBRICATING SUTURE OF 0 VICRYL. IN THE COURSE OF THE CLOSURE, THREE SEPARATE NEEDLES HAD THEIR SUTURES POP OFF AND THE LAST ONE (NEEDLE) COULD NOT BE FOUND. CONSEQUENTLY, AN X-RAY WAS ORDERED INTRAOPERATIVELY AND DEMONSTRATED THAT THE NEEDLE IS IN THE LEFT PELVIS. IT WAS SUBSEQUENTLY FOUND IN THE MUSCULAR LAYER OF THE LOWER UTERINE SEGMENT AND WAS REMOVED SURGICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL SUTURE, ABSORBABLE, NEEDLE GAM ETHICON, INC. J358H AJ2260

    Patients

    Seq Age Sex Outcome Treatment
    1 *