BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALTRAC ANASTAMOSIS RING

    MDR report key: 161994 · Received April 9, 1998

    Report

    Report Number
    1210157-1998-00002
    Event Type
    Malfunction
    Date Received
    April 9, 1998
    Report Date
    March 10, 1998
    Manufacturer
    SHERWOOD DAVIS & GECK
    Product Code
    LNN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR. COMPLAINT # DA1998-3-10-82. THIS COMPLAINT WAS DEEMED REPORTABLE ON 3/13/1998. THE ACTUAL SAMPLE WAS RETURNED AND EVALUATED. NO DEFECTS WERE OBSERVED. THE DEVICE WAS RECEIVED IN THE CLOSED POSITION, FULLY ENGAGED WITH ALL POINTS FULLY INTERLOCKED. A REVIEW OF THE LOT HISTORY WAS UNREMARKABLE. NO PREVIOUS COMPLAINTS HAVE BEEN RECEIVED AGAINST THIS LOT SINCE ITS RELEASE. CO IS UNABLE TO CONFIRM THE REPORTED PROBLEM. IN FACT, THE PRODUCT WAS RETURNED IN THE CLOSED POSITION, WHICH REPORTEDLY WAS THE PROBLEM (DEVICE WOULDN'T CLOSE).

    Description of Event or Problem · 1

    CUSTOMER REPORTS THEY COULD NOT GET THE VALTRAC DEVICE TO CLOSE DURING SURGERY. REPLACEMENT WAS NECESSARY AND THERE WAS A DELAY OF ONLY 5-10 MINUTES. THERE WAS NO PT COMPLICATION DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALTRAC ANASTAMOSIS RING BIOFRAGMENTABLE ANASTAMOSIS RING LNN SHERWOOD DAVIS & GECK NA 897019

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN