BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRELLIS 8 120X30

    MDR report key: 2973537 · Received February 22, 2013

    Report

    Report Number
    2953189-2013-00020
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 16, 2013
    Report Date
    February 7, 2013
    Manufacturer
    COVIDIEN SAN JOSE
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DHR REVIEW WAS PERFORMED ON PRODUCT CODE BVT812030, LOT# 551619, WHICH WAS MANUFACTURED IN NOVEMBER 2012 AND THE EXPIRATION DATE IS NOVEMBER 2014. THIS LOT WAS 100% VISUALLY INSPECTED WITH NO DEFECTS DETECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBITTED. (B)(4): STILL WAITING FOR DEVICE RETURN.

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE DISTAL BALLOON BURST WHILE IN THE PATIENT. NO INJURY OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78299 TRELLIS 8 120X30 CATHETER, CONTINUOUS FLUSH KRA COVIDIEN SAN JOSE BVT812030 551619

    Patients

    Seq Age Sex Outcome Treatment
    1 Other