BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B TAMPONS PRODUCTS

    MDR report key: 3063586 · Received April 17, 2013

    Report

    Report Number
    8022269-2013-00037
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 16, 2013
    Manufacturer
    MONTREAL SAN PRO
    Product Code
    HEB
    PMA / PMN Number
    K974629
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED ON (B)(4) FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (OB UNSPECIFIED US). THIS IS AN INITIAL SUBMISSION FOR THE FIRST PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8022269-2013-00037. THE MANUFACTURER REPORT NUMBER FOR THE SECOND PRODUCT IN THIS CASE IS 8022269-2013-00038. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED ON (B)(4) FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (OB UNSPECIFIED US). THIS IS FOLLOW UP SUBMISSION FOR THE FIRST PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8022269-2013-00037. THE MANUFACTURER REPORT NUMBER FOR THE SECOND PRODUCT IN THIS CASE IS 8022269-2013-00038. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED ON (B)(4) FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (OB UNSPECIFIED US). THIS IS AN INITIAL SUBMISSION FOR THE FIRST PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8022269-2013-00037. THE MANUFACTURER REPORT NUMBER FOR THE SECOND PRODUCT IN THIS CASE IS 8022269-2013-00038. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    INITIAL SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM (B)(6). FOLLOW-UP INFORMATION RECEIVED ON (B)(4) 2013 CONFIRMED THAT THE PRODUCT INVOLVED IN THIS REPORT WAS IDENTIFIED AS SAME/SIMILAR TO A US DEVICE PRODUCT. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O.B. UNSPECIFIED, VAGINALLY, DURING MENSTRUATION (FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, WHILE CHANGING THE TAMPON, SHE PULLED THE STRING OF THE OLD TAMPON WHICH CAME OUT UNATTACHED AND TAMPON GOT STUCK IN VAGINA ON TWO DIFFERENT OCCASIONS. AFTER AN UNSPECIFIED DURATION, SHE REMOVED THE TAMPON ON BOTH OCCASIONS. SHE STATED THAT SHE WAS USING OB TAMPONS IN THE PAST WITHOUT HAVING ANY PROBLEMS. THE CONSUMER DID NOT PROVIDE A VALID LOT NUMBER WITH THE COMPLAINT NOR A COMPLETE DEVICE DESCRIPTION. WITHOUT THIS INFORMATION, THE ANALYST COULD NEITHER PERFORM A MANUFACTURING AND PACKAGING BATCH RECORD REVIEW NOR PERFORM THE LOT TREND ANALYSIS AND RETAIN SAMPLE INSPECTION. THE MANUFACTURES DID NOT RECEIVE A RETURNED SAMPLE FOR EVALUATION AS OF (B)(4) 2013. THE ANALYST PERFORMED A REVIEW OF THE COMPLAINT DATA ASSOCIATED WITH THIS CATEGORY AND FOUND NO ADVERSE TREND. BASED ON THE INVESTIGATION RESULTS, DUE TO LACK OF A COMPLAINT SAMPLE, THE ABSENCE OF LOT NUMBER AND THE ABSENCE OF ADVERSE TREND, NO ASSIGNABLE CAUSE WAS IDENTIFIED. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT HAD NON-SERIOUS EVENT. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Description of Event or Problem · 1

    INITIAL SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM (B)(6). FOLLOW-UP INFORMATION RECEIVED ON (B)(4) 2013 CONFIRMED THAT THE PRODUCT INVOLVED IN THIS REPORT WAS IDENTIFIED AS SAME/SIMILAR TO A US DEVICE PRODUCT. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O.B. UNSPECIFIED, VAGINALLY, DURING MENSTRUATION (FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, WHILE CHANGING THE TAMPON, SHE PULLED THE STRING OF THE OLD TAMPON WHICH CAME OUT UNATTACHED AND TAMPON GOT STUCK IN VAGINA ON TWO DIFFERENT OCCASIONS. AFTER AN UNSPECIFIED DURATION, SHE REMOVED THE TAMPON ON BOTH OCCASIONS. SHE STATED THAT SHE WAS USING OB TAMPONS IN THE PAST WITHOUT HAVING ANY PROBLEMS. THE CONSUMER DID NOT PROVIDE A VALID LOT NUMBER WITH THE COMPLAINT NOR A COMPLETE DEVICE DESCRIPTION. WITHOUT THIS INFORMATION, THE ANALYST COULD NEITHER PERFORM A MANUFACTURING AND PACKAGING BATCH RECORD REVIEW NOR PERFORM THE LOT TREND ANALYSIS AND RETAIN SAMPLE INSPECTION. THE MANUFACTURES DID NOT RECEIVE A RETURNED SAMPLE FOR EVALUATION AS OF (B)(4) 2013. THE ANALYST PERFORMED A REVIEW OF THE COMPLAINT DATA ASSOCIATED WITH THIS CATEGORY AND FOUND NO ADVERSE TREND. BASED ON THE INVESTIGATION RESULTS, DUE TO LACK OF A COMPLAINT SAMPLE, THE ABSENCE OF LOT NUMBER AND THE ABSENCE OF ADVERSE TREND, NO ASSIGNABLE CAUSE WAS IDENTIFIED. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT HAD NON-SERIOUS EVENT. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. THE CONSUMER NOTICED THE STRING OF THE TAMPON WAS BROKEN WHILE IT WAS BEING REMOVED. THIS REPORT REMAINS NON SERIOUS. THIS REMAINS REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Description of Event or Problem · 1

    INITIAL SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM (B)(6). FOLLOW-UP INFORMATION RECEIVED ON (B)(4) 2013 CONFIRMED THAT THE PRODUCT INVOLVED IN THIS REPORT WAS IDENTIFIED AS SAME/SIMILAR TO A US DEVICE PRODUCT. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O.B. UNSPECIFIED, VAGINALLY, DURING MENSTRUATION (FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, WHILE CHANGING THE TAMPON, SHE PULLED THE STRING OF THE OLD TAMPON WHICH CAME OUT UNATTACHED AND TAMPON GOT STUCK IN VAGINA ON TWO DIFFERENT OCCASIONS. AFTER AN UNSPECIFIED DURATION, SHE REMOVED THE TAMPON ON BOTH OCCASIONS. SHE STATED THAT SHE WAS USING OB TAMPONS IN THE PAST WITHOUT HAVING ANY PROBLEMS. THE CONSUMER DID NOT PROVIDE A VALID LOT NUMBER WITH THE COMPLAINT NOR A COMPLETE DEVICE DESCRIPTION. WITHOUT THIS INFORMATION, THE ANALYST COULD NEITHER PERFORM A MANUFACTURING AND PACKAGING BATCH RECORD REVIEW NOR PERFORM THE LOT TREND ANALYSIS AND RETAIN SAMPLE INSPECTION. THE MANUFACTURES DID NOT RECEIVE A RETURNED SAMPLE FOR EVALUATION AS OF (B)(4) 2013. THE ANALYST PERFORMED A REVIEW OF THE COMPLAINT DATA ASSOCIATED WITH THIS CATEGORY AND FOUND NO ADVERSE TREND. BASED ON THE INVESTIGATION RESULTS, DUE TO LACK OF A COMPLAINT SAMPLE, THE ABSENCE OF LOT NUMBER AND THE ABSENCE OF ADVERSE TREND, NO ASSIGNABLE CAUSE WAS IDENTIFIED. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT HAD NON-SERIOUS EVENT. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. THE CONSUMER NOTICED THE STRING OF THE TAMPON WAS BROKEN WHILE IT WAS BEING REMOVED. THIS REPORT REMAINS NON SERIOUS. THIS REMAINS REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. THE ANALYST PERFORMED A REVIEW OF THE DATA ASSOCIATED WITH THE COMPLAINT AND FOUND NO ADVERSE TREND. A REVIEW OF HISTORY OF CHANGES PERFORMED ON THE DEVICE AND PROCESS IN THE O.B DEPARTMENT OVER A PERIOD OF (B)(4) WAS CARRIED OUT AND IN THIS TIME PERIOD, THE ONLY SIGNIFICANT CHANGE THAT WAS MADE TO THE STRING WAS A CHANGE OF THE SUPPLIER LOCATION. A MULTIPLE LOT TREND WAS IDENTIFIED THAT WOULD REQUIRE FURTHER ACTION. THIS REPORT REMAINS NON SERIOUS. THIS REMAINS REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164106 O.B TAMPONS PRODUCTS TAMPONS HEB MONTREAL SAN PRO OBGENCA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1