BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KLEENSPEC VAGINAL SPECULA ILLUMINATION SYSTEM

    MDR report key: 1584842 · Received January 14, 2010

    Report

    Report Number
    1316463-2010-00001
    Event Type
    Injury
    Date Received
    January 14, 2010
    Date of Event
    November 11, 2009
    Report Date
    December 15, 2009
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    HIB
    PMA / PMN Number
    K771181
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WELCH ALLYN RECEIVED UF REPORT ON 12/15/2009 DETAILING THIS EVENT. WE CONTACTED THE USER FACILITY TO DETERMINE IF THEY WERE SENDING US THE DEVICE FOR EVAL. THEY WERE NOT SENDING US THE DEVICE. THE USER FACILITY'S REP CONFIRMED THAT 2ND-DEGREE BURNS RESULTED TO THE PT. THE DEVICE WAS NOT USED IN CONFORMITY WITH ITS INTENDED USE STATEMENT. IT IS INTENDED FOR USE AS AN ILLUMINATOR (VAGINAL SPECULUM) BUT IT WAS MISTAKENLY USED AS A TRANSILLUMINATOR. THIS USE WAS CONTRARY TO THE FOLLOWING WARNINGS AND CAUTION STATEMENT IN THE USER MANUAL: "THIS PRODUCT IS FOR USE WITH THE WELCH ALLYN KLEENSPEC SINGLE-USE VAGINAL SPECULA ONLY. DO NOT USE THE ILLUMINATOR FOR ANY OTHER USE. LAMP IS HOT AND CAN CAUSE A BURN IF USED OUTSIDE OF THE VAGINAL SPECULA." THE DEVICE ITSELF HAS A SYMBOL "CAUTION, HIGH TEMPERATURES" EMBEDDED PROXIMAL TO THE POWER SWITCH.

    Description of Event or Problem · 1

    WELCH ALLYN RECEIVED A USER FACILITY REPORT ON 12/15/2009, INDICATING THAT A NURSE ACCIDENTALLY USED A VAGINAL SPEC ILLUMINATOR AS A TRANSILLUMINATOR DURING A PERIPHERAL INTRAVENOUS CATHETER START, INADVERTENTLY CAUSING 2ND-DEGREE BURNS TO THE PALM AND FOREARM OF THE PT. THE NURSE INDICATED THAT HE INTENDED TO USE A DIFFERENT DEVICE BUT MISTAKENLY USED THE VAGINAL SPEC ILLUMINATOR BECAUSE THE TWO DEVICES LOOKED SIMILAR TO HIM. THE FACILITY NOTED THAT THESE TWO DEVICES "ARE NEVER STORED TOGETHER AND WE DO NOT KNOW HOW IT GOT WHERE IT WAS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLEENSPEC VAGINAL SPECULA ILLUMINATION SYSTEM HIB WELCH ALLYN, INC. 78810 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DA Required Intervention PER THE USER FACILITY REPORT (CITED ABOVE), THERE| WERE NO OTHER THERAPIES OR DEVICES USED ON THE PT.