BEUDAMED
    FDA Adverse Event Other Summary report: N

    DAC WH TP 3MM KC-25 2N 18"

    MDR report key: 444340 · Received February 21, 2003

    Report

    Report Number
    1221601-2003-00002
    Event Type
    Other
    Date Received
    February 21, 2003
    Date of Event
    January 21, 2003
    Report Date
    February 21, 2003
    Manufacturer
    GENZYME BIOSURGERY A DIVISION OF GE
    Product Code
    GAO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS USING SUTURE NEEDLE. AFTER HANDING THE NEEDLE BACK TO THE SCRUB NURSE, IT WAS ALLEGED THAT THE TIP OF THE SUTURE HAD BROKEN OFF. A VISUAL INSPECTION AND X-RAY WERE PERFORMED. THE BROKEN PIECE WAS UNABLE TO BE DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAC WH TP 3MM KC-25 2N 18" SUTURE GAO GENZYME BIOSURGERY A DIVISION OF GE 89-5037W 548451

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other