BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXON II

    MDR report key: 1031533 · Received April 14, 2008

    Report

    Report Number
    9681850-2008-00005
    Event Type
    Injury
    Date Received
    April 14, 2008
    Report Date
    March 18, 2008
    Manufacturer
    GOSPORT - USS
    Product Code
    GAN
    PMA / PMN Number
    K951352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORRECT NUMBER OF DEVICES AND EVENTS HAS NOT BEEN REPORTED. THREE DIFFERENT LOT NUMBERS WERE REPORTED: E7B0151K, E6H0543K, AND E6E0243K.

    Description of Event or Problem · 1

    PROCEDURE TYPE: THYROIDECTOMY. ACCORDING TO THE REPORTER: "THE PROBLEM OCCURRED SEVERAL TIMES DURING THE LAST YEAR. THE CUSTOMER COMPLAINS THAT THE SUTURE BREAKS HAVING A LITTLE TENSILE STRENGTH. IN SOME CASES, PATIENTS HAD BLEEDING AND THEY HAD TO BE RE-OPENED TO ADJUST THE HEMOSTASIS." ALL OF THESE EVENTS OCCURRED IN ONE HOSPITAL. NO FURTHER DETAILS COULD BE OBTAINED ABOUT THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXON II ABSORBABLE SYNTHETIC SUTURE GAN GOSPORT - USS E7B0151K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention