BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN RAYTEC GAUZE

    MDR report key: 4859402 · Received June 16, 2015

    Report

    Report Number
    MW5043165
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Date of Event
    May 20, 2015
    Report Date
    June 16, 2015
    Manufacturer
    COVIDIEN -KENDALL
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BASIC HEART PACK HAD CONTAMINANTS IN THE RAYTEC GAUZE. PHS PACK CATALOG# 621925A; LOT 1174681; REV: 013. SMH RECEIVED REPLACEMENT PACK FROM SCV. THE RAYTEC FOUND IN THE PHS PACKS ARE MADE BY COVIDIEN - KENDALL. VENDOR ITEM #: (B)(4). FOCUSING RAYTEC (AND NOT PHS PACKS): PHS PACK ADDRESS: (B)(4). SAME REPORTER IN MW5043161- MW5043178.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392717 COVIDIEN RAYTEC GAUZE SPONGE GDY COVIDIEN -KENDALL 1174681

    Patients

    Seq Age Sex Outcome Treatment
    1 BASIC HEART PACK