BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYTEC GAUZE MADE BY COVIDIEN/KENDALL

    MDR report key: 4859440 · Received June 16, 2015

    Report

    Report Number
    MW5043173
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Date of Event
    June 4, 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

    PHS MAXILLOFACIAL PACK CATALOG# 660040, LOT# 1182285 REV 14. GROSS DEBRIS IN RAYTEC GAUZE. RAYTEC GAUZE IS MADE BY COVIDIEN/KENDALL. FOCUSING ON RAYTEC GAUZE (AND NOT PHS PACKS): PHS PACKS= (B)(4). SAME REPORTER IN MW5043161- MW5043178.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392825 RAYTEC GAUZE MADE BY COVIDIEN/KENDALL GAUZE GDY COVIDIEN-KENDALL

    Patients

    Seq Age Sex Outcome Treatment
    1 PHS MAXILLOFACIAL PACK