BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B. PROCOMFORT SUPER USA

    MDR report key: 2841206 · Received November 21, 2012

    Report

    Report Number
    8022269-2012-00157
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MONTREAL SAN PRO
    Product Code
    HEB
    PMA / PMN Number
    K023789
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FOLLOW UP SUBMISSION FOR THE THIRD PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THE THIRD PRODUCT IS 8022269-2012-00157. THE MANUFACTURER REPORT NUMBER FOR THE FIRST, SECOND AND THE FOURTH PRODUCTS ARE 8022269-2012-00155, 8022269-2012-00156 AND 8022269-2012-00158 RESPECTIVELY. THE DATE OF THIS SUBMISSION IS (B)(6) 2012. THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL FOLLOW UP INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL SUBMISSION FOR THE THIRD PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THE THIRD PRODUCT IS 8022269-2012-00157. THE MANUFACTURER REPORT NUMBER FOR THE FIRST, SECOND AND THE FOURTH PRODUCTS ARE 8022269-2012-00155, 8022269-2012-00156 AND 8022269-2012-00158 RESPECTIVELY. THE DATE OF THIS SUBMISSION IS (B)(4) 2012. THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL FOLLOW UP INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012, FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING OB PROCOMFORT SUPER, FOR MENSTRUATION (ROUTE VAGINAL, LOT NUMBER 1662M6420, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, SHE NOTICED THAT THE THREE TAMPONS HAD NO STRINGS AND FOR ANOTHER FOUR TAMPONS, THE STRING BROKE WHILE BEING REMOVED. THIS REPORT HAD NO ADVERSE EVENT AND 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 (B)(6) 2012, FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O.B PROCOMFORT SUPER, FOR MENSTRUATION (ROUTE VAGINAL, LOT NUMBER 1662M6420, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION SHE NOTICED THAT, THE THREE TAMPONS HAD NO STRINGS AND FOR ANOTHER FOUR TAMPONS THE STRING BROKE WHILE BEING REMOVED. THIS REPORT HAD NO ADVERSE EVENT AND 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 (B)(6) 2012. A SAMPLE WAS NOT RETURNED. RETAIN SAMPLE WAS VISUALLY INSPECTED AND NO NONCONFORMANCE OR MANUFACTURING DEFECTS RELATED TO STRING WERE OBSERVED. A REVIEW OF THE COMPLAINT DATA ASSOCIATED WITH THE STRING ISSUE FOUND NO ADVERSE TRENDS FOR THE O.B PROCOMFORT SUPER PRODUCT FAMILY OR THIS LOT NUMBER. BASED ON LACK OF A RETURNED SAMPLE, ACCEPTABLE DOCUMENTATION REVIEW AND ABSENCE OF TREND, THE INVESTIGATION CONCLUDES THAT THERE WAS NO EVIDENCE TO SUPPORT THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. 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
    1 O.B. PROCOMFORT SUPER USA TAMPON HEB MONTREAL SAN PRO OBPCSUUS 1662M6420

    Patients

    Seq Age Sex Outcome Treatment
    1