BEUDAMED
    FDA Adverse Event Other Summary report: N

    BASIC SET UP PACK

    MDR report key: 2135915 · Received June 14, 2011

    Report

    Report Number
    1417592-2011-00032
    Event Type
    Other
    Date Received
    June 14, 2011
    Date of Event
    January 21, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ASPEN SURGICAL
    Product Code
    LRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A PATIENT WAS UNDERGOING A COMPLEX HERNIA REPAIR. A POLYLITH SYNTHETIC PAPER MEASURING TAPE WAS LEFT IN PLACE IN THE OPERATIVE AREA DURING THE PROCEDURE. THIS IS AN ASPEN SURGICAL PRODUCT. THE SURGEON USED A LAPAROSCOPIC SUTURE PACKER TO PLACE A SURGICAL MESH ONTO THE ANTERIOR ABDOMINAL WALL. WHEN THE SURGEON WENT TO REMOVE THE MEASURING TAPE, IT HAD SOFTENED AND RIPPED, LEAVING A PORTION SANDWICHED BETWEEN THE MESH AND THE ABDOMINAL WALL. THE SURGEON OPTED TO LEAVE IT IN PLACE, RATHER THAN OPENING THE SURGICAL AREA TO RETRIEVE RETAINED PIECE.

    Description of Event or Problem · 1

    DURING A COMPLEX ABDOMINAL PROCEDURE, A MEASURING TAPE WAS LEFT SANDWICHED BETWEEN A SURGICAL MESH AND THE ABDOMINAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASIC SET UP PACK ASPEN SURGICAL RULER WITHIN PACK LRO ASPEN SURGICAL 10JD2406

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other