BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFSILK 3/0 18 BLACK CV-25 P/O

    MDR report key: 1175461 · Received September 24, 2008

    Report

    Report Number
    9612501-2008-00050
    Event Type
    Injury
    Date Received
    September 24, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 28, 2008
    Manufacturer
    SANTO DOMINGO - USS
    Product Code
    GAP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: AS THE MESENTERY WAS BEING SUTURED, THE NEEDLE POPPED OFF OF THE SUTURE. THE NEEDLE WAS FOUND, BUT THE NEEDLE TIP (1MM TO 2MM IN LENGTH) WAS MISSING FROM THE NEEDLE. ALTHOUGH THE INSIDE BODY WAS CHECKED BY IMAGING, THE BROKEN TIP COULD NOT BE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFSILK 3/0 18 BLACK CV-25 P/O NONABSORBABLE SYNTHETIC SUTURE GAP SANTO DOMINGO - USS D8A1202

    Patients

    Seq Age Sex Outcome Treatment
    1 Other