BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 3122423 · Received May 21, 2013

    Report

    Report Number
    3007303617-2013-00008
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 24, 2013
    Manufacturer
    QINGDAO P&B CO., LTD.
    Product Code
    HEB
    PMA / PMN Number
    K112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS LOT CODE WAS NOT PROVIDED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. CONSUMER HAD NOT RETURNED UNUSED PRODUCT FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT HER TAMPON CAME APART AND TAMPON PIECES REMAINED INSIDE OF HER. SHE INDICATED THAT SHE EXPELLED A 1/2" PIECE FROM HER VAGINA AND IS NOT SURE HOW LONG THIS PIECE WAS INSIDE OF HER. HER GYNECOLOGIST ORDERED AN ULTRASOUND, BUT DID NOT PRESCRIBE MEDICATION. SHE INDICATED THAT SHE HAS NOT FELT WELL FOR OVER FOUR MONTHS; AND HAS EXPERIENCED SWEATING, FEVER, A RASH ON HER LEGS, PAIN IN HER SIDE AND VAGINAL SORENESS. SHE WAS PRESCRIBED AMMONIUM LACTATE CREAM FOR HER RASH. SHE STATED THAT SHE ALSO HAS EXPERIENCED INTERMITTENT MENSTRUAL PERIODS FOR SEVERAL MONTHS. ON (B)(6) 2013, SHE STATED THAT HER RASH WAS SUBSIDING, HOWEVER, SHE EXPERIENCED A MALODOROUS VAGINAL DISCHARGE, BLOATING IN HER STOMACH, DIZZINESS AND SHORTNESS OF BREATH. THE CONSUMER INDICATED THAT HER SECONDARY FOLLOW-UP VISIT TO THE DOCTOR RESULTED IN HER PHYSICIAN PRESCRIBING HER A METRONIDAZOLE 0.75% VAGINAL GEL FOR 5 DAYS AND THAT SHE HAD A YEAST INFECTION, SHE STATES THAT SHE IS STARTING TO GET BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223599 U BY KOTEX SLEEK TAMPON HEB QINGDAO P&B CO., LTD. REGULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR