BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B NON-APPLICATOR TAMPONS

    MDR report key: 3021604 · Received March 26, 2013

    Report

    Report Number
    8022269-2013-00027
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 14, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS AN INITIAL SUBMISSION FOR THE SECOND PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8022269-2013-00027. THE MANUFACTURER REPORT NUMBER FOR THE FIRST PRODUCT IN THIS CASE IS 8022269-2013-00026. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(4) 2013. THIS IS AN INITIAL SUBMISSION FOR THE SECOND PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8022269-2013-00027. THE MANUFACTURER REPORT NUMBER FOR THE FIRST PRODUCT IN THIS CASE IS 8022269-2013-00026. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS AN INITIAL SUBMISSION FOR THE SECOND PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8022269-2013-00027. THE MANUFACTURER REPORT NUMBER FOR THE FIRST PRODUCT IN THIS CASE IS 8022269-2013-00026. 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 (B)(6), FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY INCLUDED UTERINE FIBROID FOR WHICH SHE HAD SURGERY A FEW YEARS AGO. OTHER HISTORY INCLUDED ALCOHOL USE. THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, IN (B)(6) 2013, THE CONSUMER STARTED USING O.B NON-APPLICATOR TAMPONS, VAGINALLY, ONE TAMPON EACH TIME, THREE TO FOUR TIMES PER DAY DEPENDING ON FLOW, FOR MONTHLY MENSES (LOT NUMBER 2862M7300 AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, ON (B)(6) 2013, WHEN SHE TOOK OUT THE TAMPON AT NIGHT, IT DID NOT COME OUT COMPLETELY AND SOME BITS OF COTTON FROM THE TIP OF TAMPON LEFT INSIDE HER VAGINA. THIS WAS HAPPENED ON TWO DIFFERENT OCCASIONS WITH TWO TAMPONS IN THE BOX. AFTER WHICH SHE WORE A PAD AND THE RESIDUAL COTTON CAME OUT IN NEXT MORNING. SHE DID NOT USE THE DEVICE FURTHER. SHE ALSO STATED THAT SHE HAD BEEN USING TAMPONS SINCE SHE WAS (B)(6), AND NEVER EXPERIENCED ANY EVENT. THIS REPORT HAD NON-SERIOUS ADVERSE EVENT. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED AS REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A (B)(6), CAUCASIAN, FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY INCLUDED UTERINE FIBROID FOR WHICH SHE HAD SURGERY A FEW YEARS AGO. OTHER HISTORY INCLUDED ALCOHOL USE. THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, IN (B)(6) 2013, THE CONSUMER STARTED USING O.B NON-APPLICATOR TAMPONS, VAGINALLY, ONE TAMPON EACH TIME, THREE TO FOUR TIMES PER DAY DEPENDING ON FLOW, FOR MONTHLY MENSES (LOT NUMBER 2862M7300 AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, ON (B)(6) 2013, WHEN SHE TOOK OUT THE TAMPON AT NIGHT, IT DID NOT COME OUT COMPLETELY AND SOME BITS OF COTTON FROM THE TIP OF TAMPON LEFT INSIDE HER VAGINA. THIS WAS HAPPENED ON TWO DIFFERENT OCCASIONS WITH TWO TAMPONS IN THE BOX. AFTER WHICH SHE WORE A PAD AND THE RESIDUAL COTTON CAME OUT IN NEXT MORNING. SHE DID NOT USE THE DEVICE FURTHER. SHE ALSO STATED THAT SHE HAD BEEN USING TAMPONS SINCE SHE WAS (B)(6), AND NEVER EXPERIENCED ANY EVENT. THIS REPORT HAD NON-SERIOUS ADVERSE EVENT. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED AS REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013. THE CONSUMER DID NOT CONSULT ANY HEALTHCARE PROFESSIONAL. SHE STATED THAT THE EVENT DID NOT RESOLVE. THE CONSUMER PROVIDED A VALID LOT NUMBER BUT NO RETURNED SAMPLE HAD BEEN RECEIVED. A REVIEW OF THE COMPLAINT DATA REVEALED NO LOT TREND AND NO ADVERSE TRENDS. A MANUFACTURING AND PACKAGING BATCH RECORD REVIEW REVEALED THAT THE DEVICE MET THE SPECIFICATIONS. HISTORY OF NON CONFORMANCES WAS REVIEWED AND NO NON CONFORMANCE WAS RECORDED FOR DEFECTS RELATED TO THIS COMPLAINT. HISTORY OF PROCESS OR FACILITY CHANGES WAS REVIEWED AND THERE WAS NO EVIDENCE TO SUPPORT THAT THE CHANGES MADE ARE RELATED TO THIS COMPLAINT. VISUAL INSPECTION OF THE RETAIN SAMPLE IDENTIFIED NO ANOMALIES. BASED ON THE INVESTIGATION RESULTS, NO ASSIGNABLE CAUSE WAS IDENTIFIED. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS NON-SERIOUS. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A (B)(6) FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY INCLUDED UTERINE FIBROID FOR WHICH SHE HAD SURGERY A FEW YEARS AGO. OTHER HISTORY INCLUDED ALCOHOL USE. THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, IN (B)(6) 2013, THE CONSUMER STARTED USING O.B NON-APPLICATOR TAMPONS, VAGINALLY, ONE TAMPON EACH TIME, THREE TO FOUR TIMES PER DAY DEPENDING ON FLOW, FOR MONTHLY MENSES (LOT NUMBER 2862M7300 AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, ON (B)(6) 2013, WHEN SHE TOOK OUT THE TAMPON AT NIGHT, IT DID NOT COME OUT COMPLETELY AND SOME BITS OF COTTON FROM THE TIP OF TAMPON LEFT INSIDE HER VAGINA. THIS WAS HAPPENED ON TWO DIFFERENT OCCASIONS WITH TWO TAMPONS IN THE BOX. AFTER WHICH SHE WORE A PAD AND THE RESIDUAL COTTON CAME OUT IN NEXT MORNING. SHE DID NOT USE THE DEVICE FURTHER. SHE ALSO STATED THAT SHE HAD BEEN USING TAMPONS SINCE SHE WAS (B)(6) AND NEVER EXPERIENCED ANY EVENT. THIS REPORT HAD NON-SERIOUS ADVERSE EVENT. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED AS REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. THE CONSUMER DID NOT CONSULT ANY HEALTHCARE PROFESSIONAL. SHE STATED THAT THE EVENT DID NOT RESOLVE. THE CONSUMER PROVIDED A VALID LOT NUMBER BUT NO RETURNED SAMPLE HAD BEEN RECEIVED. A REVIEW OF THE COMPLAINT DATA REVEALED NO LOT TREND AND NO ADVERSE TRENDS. A MANUFACTURING AND PACKAGING BATCH RECORD REVIEW REVEALED THAT THE DEVICE MET THE SPECIFICATIONS. HISTORY OF NON CONFORMANCES WAS REVIEWED AND NO NON CONFORMANCE WAS RECORDED FOR DEFECTS RELATED TO THIS COMPLAINT. HISTORY OF PROCESS OR FACILITY CHANGES WAS REVIEWED AND THERE WAS NO EVIDENCE TO SUPPORT THAT THE CHANGES MADE ARE RELATED TO THIS COMPLAINT. VISUAL INSPECTION OF THE RETAIN SAMPLE IDENTIFIED NO ANOMALIES. BASED ON THE INVESTIGATION RESULTS, NO ASSIGNABLE CAUSE WAS IDENTIFIED. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS NON-SERIOUS. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. RETURNED SAMPLES WERE RECEIVED. VISUAL INSPECTION OF THE RETURNED SAMPLES REVEALED NO ANOMALIES RELATED TO THIS COMPLAINT. DEVICE MET SPECIFICATION. BASED ON THE INVESTIGATION RESULTS, AND ON THE RETURNED SAMPLE, NO ASSIGNABLE CAUSE WAS IDENTIFIED. COMPLAINT DISPOSITION WAS UNDETERMINED. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS NON-SERIOUS. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123665 O.B NON-APPLICATOR TAMPONS TAMPON HEB MONTREAL SAN PRO 8004134500 2862M7300

    Patients

    Seq Age Sex Outcome Treatment
    1