BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B NON-APPLICATOR TAMPONS

    MDR report key: 3402964 · Received October 10, 2013

    Report

    Report Number
    8022269-2013-00099
    Event Type
    Malfunction
    Date Received
    October 10, 2013
    Date of Event
    September 1, 2013
    Report Date
    September 23, 2013
    Manufacturer
    MONTREAL SAN PRO
    Product Code
    HEB
    PMA / PMN Number
    K990536
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 10-OCT-2013. THIS IS AN INITIAL SUBMISSION FOR THE SECOND PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THE FIRST, THIRD, FOURTH, FIFTH AND SIXTH PRODUCT IN THIS CASE ARE 8022269-2013-00098, 8022269-2013-00100, 8022269-2013-00101, 8022269-2013-00102 AND 8022269-2013-00103 RESPECTIVELY. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS IS A FOLLOW UP SUBMISSION FOR THE SECOND PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8022269-2013-00099. THE MANUFACTURER REPORT NUMBER FOR THE FIRST, THIRD, FOURTH, FIFTH AND SIXTH PRODUCT IN THIS CASE ARE 8022269-2013-00098, 8022269-2013-00100, 8022269-2013-00101, 8022269-2013-00102 AND 8022269-2013-00103 RESPECTIVELY. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING THE O.B NON-APPLICATOR TAMPONS VAGINALLY, FOR MENSTRUATION (FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, IN (B)(6) 2013, THE WEEK OF REPORTING, SHE NOTICED THAT OVER FIVE TAMPONS STRINGS CAME COMPLETELY OFF THE TAMPON WHILE IN USE. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING THE (B)(6) NON-APPLICATOR TAMPONS VAGINALLY, FOR MENSTRUATION (FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION,IN (B)(6) 2013, THE WEEK OF REPORTING, SHE NOTICED THAT OVER FIVE TAMPONS STRINGS CAME COMPLETELY OFF THE TAMPON WHILE IN USE. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013: THIS REPORT WAS RECEIVED FROM A (B)(6) YEAR-OLD CAUCASIAN CONSUMER. THE CONSUMER DID NOT HAVE ANY KNOWN MEDICAL HISTORY AND WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. THE CONSUMER USED ONE TAMPON FOR FEMININE HYGIENE. SHE MENTIONED THAT ON AN UNSPECIFIED DATE, WHILE REMOVING THE TAMPON THE STRING CAME OFF SEPARATELY FROM THE COTTON PART OF THE TAMPON AND THE COTTON PART WAS LEFT INSIDE HER BODY. SHE FURTHER STATED THAT ON (B)(6) 2013, SHE USED THE TAMPON AGAIN AND SHE EXPERIENCED SAME EVENT AGAIN. ON THE SAME DAY, AFTER AN UNSPECIFIED DURATION, THE TAMPON WAS REMOVED. THE TAMPON WAS NOT USED FURTHER. NO LOT NUMBER WAS PROVIDED. THE MANUFACTURER DID NOT RECEIVE SAMPLE AS OF (B)(6) 2013. A REVIEW OF PRODUCT RELATED ISSUE DURING THIS PERIOD REVEALED NO CHANGES RELATED TO THIS COMPLAINT BUT THE TREND ANALYSIS REVEALED A PEAK DURING THIS PERIOD. BASED ON THE INVESTIGATION RESULTS, DUE TO LACK OF LOT NUMBER AND FIELD SAMPLE NO ASSIGNABLE CAUSE WAS IDENTIFIED. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THE REPORT WAS ASSESSED AS NON-SERIOUS AND THE COMPANY CAUSALITY WAS ASSESSED AS RELATED. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517189 O.B NON-APPLICATOR TAMPONS TAMPON HEB MONTREAL SAN PRO OBRENAUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1