BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B NON-APPLICATOR TAMPONS

    MDR report key: 3388102 · Received October 4, 2013

    Report

    Report Number
    8022269-2013-00080
    Event Type
    Malfunction
    Date Received
    October 4, 2013
    Report Date
    September 7, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL SUBMISSION FOR THE FOURTH PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8022269-2013-00080. THE MANUFACTURER REPORT NUMBER FOR THE FIRST, SECOND, THIRD, FIFTH AND SIXTH PRODUCT IN THIS CASE ARE 8022269-2013-00077, 8022269-2013-00078, 8022269-2013-00079, 8022269-2013-00081AND 8022269-2013-00082 RESPECTIVELY. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 11-NOV-2013. THIS IS FOLLOW UP SUBMISSION FOR THE FOURTH PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8022269-2013-00080. THE MANUFACTURER REPORT NUMBER FOR THE FIRST, SECOND, THIRD, FIFTH AND SIXTH PRODUCT IN THIS CASE ARE 8022269-2013-00077, 8022269-2013-00078, 8022269-2013-00079, 8022269-2013-00081 AND 8022269-2013-00082 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 O.B NON-APPLICATOR TAMPONS, VAGINALLY FOR MENSTRUATION (LOT NUMBER 1313M9275, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, WHEN TRYING TO REMOVE THE TAMPON, SHE NOTICED THAT THE STRING BROKE AND IT HAPPENED TO SIX OUT OF TEN TAMPONS THAT SHE USED. THIS REPORT HAD NO ADVERSE EVENT. THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON 07-SEP-2013 FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O.B NON-APPLICATOR TAMPONS, VAGINALLY FOR MENSTRUATION (LOT NUMBER 1313M9275, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, WHEN TRYING TO REMOVE THE TAMPON, SHE NOTICED THAT THE STRING BROKE AND IT HAPPENED TO SIX OUT OF TEN TAMPONS THAT SHE USED. THIS REPORT HAD NO ADVERSE EVENT. THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON 18-OCT-2013 THE CONSUMER PROVIDED A VALID LOT NUMBER, HOWEVER, NO SAMPLE HAS BEEN RECEIVED AS OF 11-OCT-2013. A REVIEW OF THE TRENDING DATA REVEALED NO TREND FOR THE REPORTED LOT NUMBER. INSPECTION OF RETAIN SAMPLE SHOWED NO ANOMALIES AND DEVICE MET SPECIFICATIONS. BATCH RECORD REVIEW REVEALED THAT THE PROCESS WAS EXECUTED AS PER ESTABLISHED PARAMETERS AND PROCEDURES. ALL IN-PROCESS CHECKS WERE PERFORMED WITH ACCEPTABLE RESULTS. NO INCIDENT IN REGARDS TO PROCESS DEVIATIONS OR ANY ATYPICAL SITUATION THAT MIGHT BE ASSOCIATED TO THE COMPLAINT. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504269 O.B NON-APPLICATOR TAMPONS TAMPON HEB MONTREAL SAN PRO 8004132500 1313M9275

    Patients

    Seq Age Sex Outcome Treatment
    1