BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLEENSPEC VAGINAL SPECULA

    MDR report key: 910019 · Received October 28, 2004

    Report

    Report Number
    1316463-2004-00011
    Event Type
    Malfunction
    Date Received
    October 28, 2004
    Date of Event
    January 29, 2003
    Report Date
    October 27, 2004
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    HIB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED AND NO LOT INFORMATION IS AVAILABLE. CONCLUSIONS: DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    PLASTIC VAGINAL SPECULA BROKE DURING USE CAUSING A LACERATION TO VAGINAL WALL NOT REQUIRING INTERVENTION.

    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