BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLEENSPEC 590 SERIES DISP VAGINAL SPECULA

    MDR report key: 1900903 · Received November 10, 2010

    Report

    Report Number
    1316463-2010-00010
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    HIB
    PMA / PMN Number
    K941272
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IS CURRENTLY UNDER EVAL BY WELCH ALLYN. EVAL, RESULTS: VAGINAL SPECULUM.

    Description of Event or Problem · 1

    WELCH ALLYN BECAME AWARE OF AN INCIDENT WHERE A FEMALE PT RECEIVED A 1 CM WOUND ON THE RIGHT LATERAL WALL OF HER VAGINA AFTER THE VAGINAL SPEC BROKE IN HALF LONGITUDINALLY ALONG THE BLADE DURING A PELVIC EXAM. PT WAS PRESCRIBED ANTIBIOTICS AND PERCOCET. THE CUSTOMER DID NOT PROVIDE A PT IDENTIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLEENSPEC 590 SERIES DISP VAGINAL SPECULA HIB WELCH ALLYN, INC. 59001

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR