BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA

    MDR report key: 2022556 · Received February 16, 2011

    Report

    Report Number
    1316463-2011-00005
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    December 31, 2010
    Report Date
    February 3, 2011
    Manufacturer
    WELCH ALLYN
    Product Code
    HIB
    PMA / PMN Number
    K941272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT STATED THAT ON (B)(6) 2010 DURING INSERTION OF A MEDIUM SIZED DISPOSABLE SPECULUM, THE BOTTOM BILL SNAPPED, LEAVING JAGGED EDGES. TWO SUPERFICIAL LACERATIONS TO THE VAGINAL WALL WITH A SMALL AMOUNT OF BLEEDING WAS IMMEDIATELY NOTED. THE BROKEN SPECULUM WAS REMOVED. A METAL SPECULUM WAS INSERTED AND THE EXAM COMPLETED. NEITHER LACERATIONS WERE GREATER THAN TWO MILLIMETERS IN LENGTH. THE PT REPORTED SORENESS AND MODERATE AMOUNT OF BLEEDING OVER THE WEEKEND AND RETURNED FOR A F/U EXAMINATION ON (B)(6) 2011. THE LACERATION ON THE INTERNAL RIGHT SIDE OF VAGINAL WALL WAS COMPLETELY HEALED AND THE MORE EXTERNAL LACERATION ON THE LEFT SIDE OF THE VAGINAL WALL WAS ALMOST HEALED. THE LACERATIONS DID NOT REQUIRE ANY MED TREATMENT OR INTERVENTION AND THE PT IS FINE. 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 59001

    Patients

    Seq Age Sex Outcome Treatment
    1