BEUDAMED
    FDA Adverse Event Summary report: N

    SNOWDEN-PENCER TEBBETTS

    MDR report key: 3861469 · Received May 23, 2014

    Report

    Report Number
    3861469
    Date Received
    May 23, 2014
    Date of Event
    March 3, 2014
    Report Date
    May 23, 2014
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    GCJ
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FULL THICKNESS SKIN BURN OF RIGHT PREAXILLARY SKIN FROM HEATED LIGHTED RETRACTOR. IT WAS DISCOVERED THAT A FIBER OPTIC LIGHT CABLE OF 5.0 MM WAS BEING USED WHICH IS AGAINST THE MANUFACTURER'S WARNING.======================MANUFACTURER RESPONSE FOR BREAST RETRACTOR, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================THEY WERE AWARE AND POINTED OUT THEIR INSERT WARNING TO HAVE THE CORRECT FIBER OPTIC CABLE NO LARGER THAN 3.5MM FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309103 SNOWDEN-PENCER TEBBETTS RETRACTOR, FIBEROPTIC GCJ CAREFUSION 2200, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR LIGHT SOURCE ISOLUX, MODEL #1300 XSB LIGHT CABLE,| MODEL# 233-050-064 STRYKER