BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOTEX NATURAL BALANCE : TAMPON, MENSTRUAL, UNSCENTED : HEB

    MDR report key: 7624468 · Received June 21, 2018

    Report

    Report Number
    2381757-2018-00015
    Event Type
    Malfunction
    Date Received
    June 21, 2018
    Date of Event
    January 6, 2018
    Report Date
    September 5, 2018
    Manufacturer
    KIMBERLY-CLARK CORPORATION CONWAY MILL
    Product Code
    HEB
    UDI-DI
    00036000998436
    PMA / PMN Number
    K896994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) AND QUALITY RECORDS WERE REVIEWED. THESE DOCUMENTS DEMONSTRATE THAT PROCEDURES WERE CORRECTLY FOLLOWED. NO OTHER SIMILAR OR RELATED COMPLAINTS FOR THE REPORTED LOT WERE FOUND. COMPLAINTS WHICH ARE SERIOUS IN NATURE ARE REVIEWED ON A REGULAR BASIS OR FOR DUE CAUSE TO PROVIDE VISIBILITY AND ESCALATION. IN ADDITION, COMPLAINTS ARE ALSO MONITORED FOR TRENDING ON A MONTHLY CADENCE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CORRECTION OF DATA BASED ON NEW INFORMATION RECEIVED: DATE OF EVENT - ON (B)(6) 2018 CONSUMER STATED THAT INCIDENT OCCURED 'ABOUT A MONTH AGO'. HOWEVER, MEDICAL RECORDS SHOW THAT THE EVENT TOOK PLACE ON (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP MDR WAS PREVIOUSLY SUBMITTED UNDER THE INCORRECT MFR NUMBER 2381757-2018-13169. THE CORRECT MFR NUMBER IS 2381757-2018-00015. CORRECTIONS: BRAND NAME: UPDATED FROM U BY KOTEX SECURITY TO KOTEX NATURAL BALANCE. PREMARKET IDENTIFICATION #: UPDATED FROM K141294 TO K896994.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT THE TAMPON STRING BROKE OFF FROM THE PLEDGET, LEAVING THE PLEDGET INSIDE OF HER. SHE WENT TO THE EMERGENCY ROOM AND THEY USED FORCEPS TO REMOVE THE PLEDGET, WHICH LEFT PIECES BEHIND. ALL OF THE PLEDGET WAS SUCCESSFULLY REMOVED AND THE CONSUMER IS DOING FINE NOW. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THIS IS A FOLLOW-UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467650 KOTEX NATURAL BALANCE : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB KIMBERLY-CLARK CORPORATION CONWAY MILL SUPER AC525266X1507 00036000998436

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR