BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA

    MDR report key: 3023079 · Received February 27, 2013

    Report

    Report Number
    1316463-2013-00001
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    WELCH ALLYN
    Product Code
    HIB
    PMA / PMN Number
    K941272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS NOT BEEN RETURNED TO WELCH ALLYN FOR EVALUATION. WE ARE SUBMITTING THIS REPORT IN AN ABUNDANCE OF CAUTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    DURING A PROCEDURE TO REMOVE AN IUD, THE HEALTH CARE PROVIDER INSERTED THE MEDIUM SIZED SPECULUM, SPREAD THE BLADES OPEN AND LOCKED THEM IN PLACE. SECONDS AFTER LOCKING THE SPECULUM, THE FIRST INCH AND A HALF OF THE TOP BLADE CRACKED AND BROKE OFF INSIDE THE PATIENT'S VAGINA. THE PATIENT FELT A SHARP JAB AND PINCH. THE PROVIDER SUCCESSFULLY REMOVED THE BROKEN SPECULUM FROM THE PATIENT. DUE TO THE TYPE OF PROCEDURE THE PROVIDER WAS UNABLE TO TELL IF THE PATIENT'S TISSUE WAS AFFECTED. THE CUSTOMER DID NOT PROVIDE A PATIENT IDENTIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85256 KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA HIB WELCH ALLYN 59001

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR