BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAMPON, MENSTRUAL, UNSCENTED

    MDR report key: 6341512 · Received February 17, 2017

    Report

    Report Number
    3003701733-2017-00004
    Event Type
    Death
    Date Received
    February 17, 2017
    Date of Event
    August 14, 2015
    Report Date
    March 17, 2017
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    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. THE MANUFACTURER OF THE TAMPON WAS NEVER IDENTIFIED/CONFIRMED.

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION RECEIVED BY KIMBERLY-CLARK, A SECURITY® TAMPON MAY HAVE BEEN USED IN THIS ADVERSE EVENT. HOWEVER, THE MANUFACTURER OF THE TAMPON WAS NEVER IDENTIFIED. A MEDICAL DEVICE REPORT HAD NOT BEEN FILED FOR THIS ADVERSE EVENT WITHIN 30 DAYS OF RECEIPT OF NOTICE BECAUSE IT DID NOT COME IN THROUGH OUR CONSUMER SERVICES DEPARTMENT. AS A RESULT OF THIS INCIDENT, WE ARE TAKING INTERNAL MEASURES TO CORRECT OUR PROCESS. THIS INCLUDES TRAINING THE REQUIRED TEAM MEMBERS FOR EVENTS THAT MAY OR MAY NOT INVOLVE OUR PRODUCTS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE MOTHER REPORTED HER (B)(6) DAUGHTER HAD THE STOMACH FLU FOR A WEEK WITH VOMITING THE LAST TWO DAYS OF THE WEEK. HER DAUGHTER WOKE UP AND WAS SHORT OF BREATH. WHILE SHE WAS GETTING DRESSED TO GO TO THE ER SHE PASSED OUT. EMS WAS CALLED TO THEIR HOME, HER DAUGHTER WAS FOUND UNRESPONSIVE AND ASYSTOLIC, CPR WAS DONE. SHE WAS UNRESPONSIVE UPON ARRIVAL TO THE EMERGENCY ROOM. CPR AND MEDS WERE ATTEMPTED FOR AN HOUR, UNFORTUNATELY A NORMAL HEART RHYTHM WAS NEVER OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122885 TAMPON, MENSTRUAL, UNSCENTED HEB KIMBERLY-CLARK CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death