BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 3232367 · Received December 11, 2012

    Report

    Report Number
    9611594-2012-00150
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    August 27, 2012
    Report Date
    August 30, 2012
    Manufacturer
    AVENT SA DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K113036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL MEDICAL ASSESSMENT INDICATED THAT THE CONSUMER'S SYMPTOMS ARE CONSISTENT WITH PELVIC INFLAMMATORY DISEASE DUE TO TAMPON MISUSE. A DOCUMENT AND RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. DOCUMENTATION ASSESSED INCLUDES: MFG, QUALITY AUDIT, PRODUCTION, RAW MATERIALS AND DEVICE HISTORY RECORDS. THIS ASSESSMENT FOUND NO ANOMALIES THAT MAY HAVE ATTRIBUTED TO THE REPORTED ISSUE; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. COMPLAINT SAMPLE WAS NOT RETURNED; THEREFORE, A PRODUCT EVAL COULD NOT BE PERFORMED. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT SHE EXPERIENCED STOMACH PAIN, FEVER, A FOUL ODOR AND STOMACH BLOATING FOR OVER A MONTH AFTER TAMPON USAGE. SHE STATED THAT SHE VISITED HER DOCTOR FOR AN UNRELATED ISSUE AND AFTER USING THE REST ROOM A TAMPON WAS DISPELLED FROM HER VAGINA. SHE INDICATED THAT THE TAMPON HAD BEEN INSERTED FOR OVER A MONTH. SHE THOUGHT HER SYMPTOMS WERE RELATED TO FOOD POISONING, BUT HER DOCTOR PERFORMED BLOOD TEST AND COULD NOT CONFIRM THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U BY KOTEX SLEEK TAMPON HEB AVENT SA DE R.L. DE C.V. REGULAR AA206601B

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR