BEUDAMED
    FDA Adverse Event Other Summary report: N

    KLEENSPEC VAGINAL SPECULA

    MDR report key: 528101 · Received June 2, 2004

    Report

    Report Number
    1316463-2004-00004
    Event Type
    Other
    Date Received
    June 2, 2004
    Date of Event
    May 14, 2004
    Report Date
    June 1, 2004
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    HIB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VAGINAL SPECULA BROKE DURING A PROCEDURE CAUSING INTERNAL SCRATCHES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLEENSPEC VAGINAL SPECULA VAGINAL SPECULA HIB WELCH ALLYN, INC. 58001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other