BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE PURSTRING 65 INSTRUMENT

    MDR report key: 1724192 · Received June 10, 2010

    Report

    Report Number
    2647580-2010-00557
    Event Type
    Injury
    Date Received
    June 10, 2010
    Date of Event
    May 18, 2010
    Report Date
    May 19, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDJ
    PMA / PMN Number
    K901107
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOIDECTOMY. ACCORDING TO THE REPORTER: THE DEVICE PRESSED TOGETHER TOO MUCH TISSUE. THEREFORE, BOTH SIDES OF THE INTESTINE WILL BE FIXED TOGETHER WITH THE PERFORATED NEEDLE AND FATHOM. A RE-SECTION OF THE INTESTINE WAS NECESSARY, BUT IN THIS CASE NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE PURSTRING 65 INSTRUMENT SINGLE USE INSTRUMENT WITH MONOSOF GDJ USSC PUERTO RICO 1111

    Patients

    Seq Age Sex Outcome Treatment
    1