BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFSILK 3/0 BK 12X18 PRE-CUT WAX-RACE

    MDR report key: 1202932 · Received October 17, 2008

    Report

    Report Number
    9612501-2008-00056
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 22, 2008
    Manufacturer
    SANTO DOMINGO-USS
    Product Code
    GAP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: KIDNEY TRANSPLANT. ACCORDING TO THE REPORTER: DURING THE PROCEDURE, A PIECE OF HARD PLASTIC, BELIEVED TO BE FROM THE PACKAGING OF THE SUTURE TIE, WAS FOUND IN THE ABDOMEN OF THE PT AND RETRIEVED. THE PIECE OF PLASTIC IS BELIEVED TO HAVE CAUSED A VENOUS BLEED, 250 CC OF BLOOD LOSS. THE PT HAS RECOVERED, NO ILL EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFSILK 3/0 BK 12X18 PRE-CUT WAX-RACE NON-ABSORBABLE, BRAIDED SUTURE GAP SANTO DOMINGO-USS D7L268

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R