BEUDAMED
    FDA Adverse Event Summary report: N

    KLEENSPEC VAGINAL SPECULA ILLUMINATION

    MDR report key: 2653892 · Received June 25, 2012

    Report

    Report Number
    2653892
    Date Received
    June 25, 2012
    Date of Event
    March 27, 2012
    Report Date
    June 25, 2012
    Manufacturer
    WELCH ALLYN
    Product Code
    HIB
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    KLEENSPEC VAGINAL SPECULA ILLUMINATION SYSTEM WAS USED AS A LIGHT SOURCE FOR ILLUMINATION WITHOUT THE PLASTIC SPECULUM. THE LIGHT BULB BECOMES WARM, TO HOT TO THE TOUCH AT THE TIP OF THE BULB WHILE THE SIDES REMAIN COOL TO TOUCH PROVIDING NO INDICATION THE BULB GETS AS HOT AS IT DOES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLEENSPEC VAGINAL SPECULA ILLUMINATION VAGINAL SPECULUM LIGHT HIB WELCH ALLYN IPX7 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO