BEUDAMED
    FDA Adverse Event Other Summary report: N

    KLEEN SPEC

    MDR report key: 428477 · Received November 14, 2002

    Report

    Report Number
    1316463-2002-00005
    Event Type
    Other
    Date Received
    November 14, 2002
    Date of Event
    August 18, 2002
    Report Date
    November 11, 2002
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    HIB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SINGLE-USE VAGINAL SPECULUM BROKE AFTER INSERTION CAUSING MINOR INJURY TO VAGINAL WALL. SOME BLEEDING WAS NOTED WHICH RESOLVED ITSELF SPONTANEOUSLY. THE BROKEN PIECE WAS REMOVED FROM THE VAGINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLEEN SPEC SINGLE USE - VAGINAL SPECULUM HIB WELCH ALLYN, INC. 58001 H190580012

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other