BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE CHEMOSITE IMPLANTABLE ARTERIAL ACCESS SYSTEM

    MDR report key: 100247 · Received June 19, 1997

    Report

    Report Number
    1219930-1997-01335
    Event Type
    Malfunction
    Date Received
    June 19, 1997
    Date of Event
    May 22, 1997
    Report Date
    May 22, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    09/15/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE LEAKED. ANOTHER PORT WAS USED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE CHEMOSITE IMPLANTABLE ARTERIAL ACCESS SYSTEM Implant IMPLANTABLE DRUG DELIVERY SYSTEM LJT UNITED STATES SURGICAL CORP. NA N7A51

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN