BEUDAMED
    FDA Adverse Event Other Summary report: N

    PEDI PACK, RADIOPAQUE GAUZE WITHIN

    MDR report key: 2253437 · Received September 10, 2011

    Report

    Report Number
    1417592-2011-00049
    Event Type
    Other
    Date Received
    September 10, 2011
    Date of Event
    August 15, 2011
    Report Date
    September 7, 2011
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GDY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A PREMATURE INFANT UNDERWENT AN ABDOMINAL LAPAROSCOPIC PROCEDURE. A FEW HRS LATER SOMETHING WAS IDENTIFIED ON X-RAY. THE PT WAS RETURNED TO SURGERY AND A 2-3MM RADIOPAQUE THREAD WAS REMOVED. THE SAMPLE WAS NOT RETAINED FOR EVAL. THE ACCOUNT BELIEVED IT CAME FROM THE GAUZE USED DURING THE PREVIOUS SURGERY. UNUSED SAMPLES OF GAUZE WERE RETURNED AND EVALUATED. THE ISSUE COULD NOT BE CONFIRMED. WE HAVE NO WAY OF KNOWING IF THE GAUZE WAS INADVERTENTLY CUT DURING THE PROCEDURE. WE HAVE NO OTHER SIMILAR REPORTS OF THIS NATURE FOR THIS PRODUCT. NO CORRECTIVE ACTION TO BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    A PREMATURE INFANT UNDERWENT AN EXPLORATORY LAPAROSCOPIC ABDOMINAL PROCEDURE. A F/U X-RAY IDENTIFIED A FOREIGN OBJECT. THE PT WAS TAKEN BACK TO SURGERY AND 2-3MM PIECE OF RADIOPAQUE THREAD WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDI PACK, RADIOPAQUE GAUZE WITHIN NONE GDY MEDLINE INDUSTRIES, INC. 11FB7222

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention