BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXON II 6-0 45CM DR-10

    MDR report key: 224448 · Received May 20, 1999

    Report

    Report Number
    9681850-1999-00003
    Event Type
    Injury
    Date Received
    May 20, 1999
    Report Date
    April 23, 1999
    Manufacturer
    THE KENDALL CO., (UK) LTD.
    Product Code
    GAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SUTURE WAS USED DURING A NEPHROPYELOPLASTY PROCEDURE. REPORTEDLY, THE SUTURE BROKE. THE SURGEON PERFORMED A RE-OPERATION TO CORRECT THE CONDITION. THE HOSPITAL HAS REPORTED THE PATIENT'S CONDITION IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXON II 6-0 45CM DR-10 Implant SYNTHETIC ABSORBABLE SUTURE GAN THE KENDALL CO., (UK) LTD. NA 888948

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Required Intervention