BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LE DEXON 2-0 R 4/8 75CM X 40

    MDR report key: 286941 · Received July 19, 2000

    Report

    Report Number
    9681850-2000-00028
    Event Type
    Malfunction
    Date Received
    July 19, 2000
    Date of Event
    February 11, 2000
    Report Date
    February 25, 2000
    Manufacturer
    THE KENDALL COMPANY (UK) LTD.
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SUTURE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE NEEDLE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LE DEXON 2-0 R 4/8 75CM X 40 SYNTHETIC ABSORBABLE SUTURE GAN THE KENDALL COMPANY (UK) LTD. NA 896784H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN