BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB

    MDR report key: 14550906 · Received May 31, 2022

    Report

    Report Number
    3011109575-2022-00216
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    April 24, 2022
    Report Date
    December 19, 2022
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    PMA / PMN Number
    K172118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONSUMER PROVIDED TWO POSSIBLE LOT CODES, NN204913C1712 (REGULAR ABSORBENCY) AND (B)(4) (SUPER ABSORBENCY). THE INVESTIGATION CONDUCTED FOUND NO PRODUCT DEFECTS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DHR RECORDS SHOW THE LOTS WERE PRODUCED ACCORDING TO THE SPECIFICATION AND MET THE ACCEPTANCE CRITERIA FOR PRODUCT RELEASE. FDA ABSORBENCY LEVELS AND MICROBIOLOGICAL TEST RESULTS WERE WITHIN THE ACCEPTABLE RANGE. THE INSPECTION OF EIGHT UNUSED TAMPONS RECEIVED FROM THE CONSUMER FOUND NO DEFECTS OR ANOMALIES.

    Additional Manufacturer Narrative · 0

    THE PRODUCT LABELING AND USAGE INSTRUCTIONS STATE: "ATTENTION: TAMPON USE HAS BEEN ASSOCIATED WITH TOXIC SHOCK SYNDROME (TSS). TSS IS A RARE BUT SERIOUS DISEASE THAT MAY CAUSE DEATH. READ AND SAVE THE ENCLOSED INFORMATION. USE FOR 8 HOURS MAXIMUM." AND "CHANGE YOUR TAMPON AT LEAST EVERY 4 TO 8 HOURS." RESPECTIVELY.

    Description of Event or Problem · 0

    THE CONSUMER'S MOTHER REPORTED THAT ON THE EVENING OF (B)(6) 2022 THE CONSUMER BEGAN VOMITING AND HAD A FEVER. THE FOLLOWING DAY, SHE ALLEGEDLY TURNED BLUE AROUND THE MOUTH AND WAS TAKEN TO URGENT CARE. SHE HAD A HEART RATE OF 153BPM AND FEVER OF 103F. COVID/FLU TESTS WERE NEGATIVE. THE URGENT CARE DOCTOR ADVISED THEY GO TO CHILDREN¿S HOSPITAL WHERE THE CONSUMER WAS ADMITTED FOR 6 DAYS. SHE RECEIVED TREATMENT IN THE ICU BETWEEN (B)(6) 2022 AND (B)(6) 2022, AND THEN MOVED TO THE GENERAL WARD UNTIL HER DISCHARGE ON 4/30/2022. THE CONSUMER WAS TREATED WITH UNSPECIFIED IV ANTIBIOTICS AND IV BLOOD PRESSURE MEDICATIONS FOR DECREASING HEART RATE, UNSTABLE BLOOD PRESSURE, AND A COLLAPSED RIGHT LUNG. SHE WAS REPORTED TO HAVE BEEN DIAGNOSED WITH TOXIC SHOCK SYNDROME; THE SELECT STRAIN OF BACTERIA HAS NOT BEEN PROVIDED. UPON DISCHARGE FROM THE HOSPITAL, SHE RECEIVED ORAL ANTIBIOTICS FOR 8 MORE DAYS AND HAD UNSPECIFIED BLOOD WORK DAILY. SHE ALSO VISITED HER PEDIATRICIAN TO REVIEW HER BLOOD WORK AND WAS REPORTED TO BE IMPROVING.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATES THE CONSUMER PLACED HER LAST TAMPON AT 1900 ON (B)(6) 2022, AND WAS LEFT IN PLACE UNTIL 1430 ON (B)(6) 2022, FOR A TOTAL OF 19.5 HOURS. ADDITIONAL SYMPTOM REPORTED OF RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2679821 U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female Required Intervention| H| L