BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA

    MDR report key: 2090515 · Received April 20, 2011

    Report

    Report Number
    1316463-2011-00008
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    HIB
    PMA / PMN Number
    K941272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICES HAVE NOT BEEN RETURNED TO WELCH ALLYN FOR EVAL. VAGINAL SPECULUM.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED WELCH ALLYN VAGINAL SPECULUMS CRACKED IN TWO PTS AND A TOTAL OF SIX SPECULUMS WERE CRACKED OUT OF THEIR BOX OF TWENTY FOUR. THE CLINICIAN NOTICED ONE SPECULUM THAT HAD A LITTLE CRACK IN IT WHEN THE PHYSICIAN TOOK IT OUT OF STORAGE. NEITHER PT WAS AWARE THAT THE SPECULUM HAD BROKEN AND NO PT INJURIES WERE REPORTED. 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. 59000

    Patients

    Seq Age Sex Outcome Treatment
    1