BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXON 3-0 30" T-5

    MDR report key: 222541 · Received May 7, 1999

    Report

    Report Number
    9681850-1999-00002
    Event Type
    Malfunction
    Date Received
    May 7, 1999
    Report Date
    April 7, 1999
    Manufacturer
    THE KENDALL CO., (UK) LTD.
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SUTURE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SUTURE BROKE AND THE WOUND DEHISCENCED. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPTITAL HAS REPORTED NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXON 3-0 30" T-5 Implant SYNTHETIC ABSORBABLE SUTURE GAN THE KENDALL CO., (UK) LTD. NA 079317G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN