BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA

    MDR report key: 2000600 · Received February 2, 2011

    Report

    Report Number
    1316463-2011-00002
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    WELCH ALLYN
    Product Code
    HIB
    PMA / PMN Number
    K941272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO WELCH ALLYN AND IS CURRENTLY UNDER EVALUATION. RESULTS CODE: VAGINAL SPECULUM.

    Description of Event or Problem · 1

    WELCH ALLYN RECEIVED A COMPLAINT THAT DURING AN EXAMINATION A PT EXPERIENCED DISCOMFORT AS A RESULT OF SPECULA BREAKING SPONTANEOUSLY WHILE INSIDE VAGINA. NO INJURY WAS REPORTED RELATED TO THIS EVENT. 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 59000

    Patients

    Seq Age Sex Outcome Treatment
    1