BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE CHEMOSITE TWO-PIECE POLYURETHANE SYSTEM

    MDR report key: 117012 · Received August 27, 1997

    Report

    Report Number
    1219161-1997-01117
    Event Type
    Malfunction
    Date Received
    August 27, 1997
    Date of Event
    July 25, 1997
    Report Date
    July 29, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    LCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED ON JULY 25, 1997. REPORTEDLY, THE CATHETER WAS BLOCKED. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE CHEMOSITE TWO-PIECE POLYURETHANE SYSTEM IMPLANTABLE VENOUS ACCESS SYSTEM LCJ UNITED STATES SURGICAL CORP. NA C6A05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN