BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXON II 18" PRE-4

    MDR report key: 288434 · Received August 2, 2000

    Report

    Report Number
    1219161-2000-00724
    Event Type
    Malfunction
    Date Received
    August 2, 2000
    Date of Event
    June 21, 2000
    Report Date
    July 7, 2000
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    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 18" PRE-4 SYNTHETIC ABSORBABLE SUTURE GAN UNITED STATES SURGICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR