BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALTRAC ANASTMOSIS RING

    MDR report key: 159394 · Received March 25, 1998

    Report

    Report Number
    1210157-1998-00001
    Event Type
    Malfunction
    Date Received
    March 25, 1998
    Report Date
    February 23, 1998
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    LNN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED. THE PRODUCT IS INTENDED TO BREAKDOWN WITHIN 2-3 WEEKS. PHOTOS WERE SENT OF THE DEVICE. THE UNIT WAS LITERALLY SHATTERED INTO FRAGMENTS AND CONTAMINATED SO THE INITIAL BREAKPOINT COULD NOT BE ESTABLISHED. INFO FROM THE PHYSICIAN INDICATED THERE WAS NO ADVERSE PT OUTCOME. LOT HISTORY REVIEW FOUND THE PRODUCT MET ALL ACCEPTANCE CRITERIA AT RELEASE. THERE HAS BEEN ONE PRIOR UNCONFIRMED COMPLAINT INDICATING "POSSIBLE BAD LOT". WHAT EVER CAUSED THE PROBLEM WAS OBVIOUSLY TRANSITORY, POSSIBLY PT RELATED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS, WHEN THE DR USED VALTRAC FOR ANASTOMOSIS BETWEEN THE ILEUM AND THE COLON AT THE COLECTOMY, THE VALTRAC BROKE. IN THIS HOSP THE VALTRAC HAS BEEN USED ABOUT ONE HUNDRED TIMES BEFORE. THIS WAS THE FIRST SUCH INCIDENT. IT WAS USED IN A USUAL PROCEDURE AND NOT RESTERILIZED. NO PT INJURY IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALTRAC ANASTMOSIS RING ANASTAMOSIS RING LNN SHERWOOD DAVIS AND GECK NA 894098

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN