BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TICRON 0 BLUE 30" GS-22

    MDR report key: 1163123 · Received September 16, 2008

    Report

    Report Number
    9612501-2008-00049
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 21, 2008
    Manufacturer
    SANTO DOMINGO - USS
    Product Code
    GAW
    PMA / PMN Number
    K930591
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: HIGH UTERO SUSPENSION. ACCORDING TO THE REPORTER: THERE WAS A SUTURE BREAKAGE DURING THE CASE WHICH CAUSED AN ADDITIONAL 45 MINUTES TO THE CASE. ONE OF THE TWO SUSPENSION KNOTS BROKE. RESTARTED THAT SIDE AGAIN, HAD TO SUSPEND WITH ONLY ONE SIDE KNOT. AN ATTEMPT WAS MADE TO REDO THE SECOND KNOT, BUT DUE TO OTHER COMPLICATION THEY HAD TO USE ONLY ONE SUSPENSION KNOT. THE CASE WAS THEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TICRON 0 BLUE 30" GS-22 NON-ABSORBABLE SYNTHETIC SUTURE GAW SANTO DOMINGO - USS D7E1538

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention