BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXON II 1 75CM BI-COLOR T-25

    MDR report key: 296579 · Received September 13, 2000

    Report

    Report Number
    1219161-2000-00855
    Event Type
    Malfunction
    Date Received
    September 13, 2000
    Date of Event
    July 28, 2000
    Report Date
    August 14, 2000
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SUTURE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE NEEDLE BROKE. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXON II 1 75CM BI-COLOR T-25 SYNTHETIC ABSORBABLE SUTURE GAN UNITED STATES SURGICAL CORP. NA 780861H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN