BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLEENSPEC VAGINAL SPECULA

    MDR report key: 910651 · Received October 28, 2004

    Report

    Report Number
    1316463-2004-00023
    Event Type
    Malfunction
    Date Received
    October 28, 2004
    Date of Event
    October 22, 2003
    Report Date
    October 27, 2004
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    HIB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE WAS DISCARDED BY USER. CONCLUSIONS: DEVICE NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    PLASTIC VAGINAL SPECULA BROKE DURING USE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLEENSPEC VAGINAL SPECULA NONMETAL VAGINAL SPECULUM HIB WELCH ALLYN, INC. 58000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR