BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXON SIZE 1

    MDR report key: 1101385 · Received August 5, 2008

    Report

    Report Number
    9681850-2008-00014
    Event Type
    Injury
    Date Received
    August 5, 2008
    Report Date
    July 9, 2008
    Manufacturer
    GOSPORT - USS
    Product Code
    GAN
    PMA / PMN Number
    K990951
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 08/05/2008. THERE ARE FOUR INCIDENTS REPORTED FROM THIS SAME DOCTOR AND HOSPITAL. THE INCIDENTS ARE REPORTED UNDER MDR ACCESS NUMBERS 9681850-2008-00013, 00014, 00015, AND 00016.

    Description of Event or Problem · 1

    PROCEDURE: RADICAL PROSTATECTOMY. ACCORDING TO THE REPORTER: THE SUTURE WAS USED FOR A MULTI-LAYER WOUND CLOSURE. THE SUTURE ALMOST FULLY DISINTEGRATED AND THE WOUND DEHISCED BETWEEN THE 5TH AND 7TH DAY AFTER SURGERY. A RE-OPERATION WAS PERFORMED TO TREAT THE WOUND DEHISCENCE. NO FURTHER INVESTIGATION COULD BE OBTAINED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXON SIZE 1 SYNTHETIC ABSORBABLE SUTURE GAN GOSPORT - USS E7D0121S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R