BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O B TAMPONS SUPER ABSORBENCY

    MDR report key: 2720297 · Received August 30, 2012

    Report

    Report Number
    8022269-2012-00144
    Event Type
    Malfunction
    Date Received
    August 30, 2012
    Report Date
    August 17, 2012
    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
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED (B)(4) 2012, FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (OB SUPER NON-APPLICATOR 20S). THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL FOLLOW UP INFORMATION IS RECEIVED. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8022269-2012-00144. THE INITIAL SUBMISSION FOR THE FIRST PRODUCT AND THIRD PRODUCT IN THIS CASE HAS THE MANUFACTURER REPORT NUMBER 8022269-2012-00143 AND 8022269-2012-00145 RESPECTIVELY.

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED 30-AUG-2012 FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (OB SUPER NON-APPLICATOR 20S). THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL FOLLOW UP INFORMATION IS RECEIVED. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8022269-2012-00144. THE INITIAL SUBMISSION FOR THE FIRST PRODUCT AND THIRD PRODUCT IN THIS CASE HAS THE MANUFACTURER REPORT NUMBER 8022269-2012-00143 AND 8022269-2012-00145 RESPECTIVELY.

    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 (B)(6). THE MEDICAL HISTORY OF THE CONSUMER AND THE CONCOMITANT MEDICATION WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O B TAMPONS SUPER ABSORBENCY, VAGINALLY FOR MENSTRUATION (LOT NUMBER 2851M4072, EXPIRATION DATE AND FREQUENCY UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, SHE NOTICED THAT THE STRINGS WERE MISSING FROM THREE OF THE TAMPONS WHILE USING AND IT WAS AWKWARD TO GET TAMPONS OUT. SHE ALSO STATED THAT THE DEVICE DID NOT ABSORB PROPERLY. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED AS REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012. VALID LOT NUMBER WAS PROVIDED, BUT NO SAMPLE WAS RETURNED. REVIEW OF PACKAGING BATCH RECORD AND MANUFACTURING ISSUES FOR THE REPORTED LOT NUMBER REVEALED NO MANUFACTURING ISSUES. DETECTORS TO DETECT THE PRESENCE OF THE STRING AT THE BASE OF EACH TAMPON, WERE IN PLACE AND WERE FUNCTIONAL DURING THE PRODUCTION OF THIS LOT. VISUAL INSPECTION OF THE RETAIN SAMPLE REVEALED NO NONCONFORMANCE OR MANUFACTURING DEFECTS. REVIEW OF COMPLAINT DATA FOUND NO ADVERSE TRENDS AND NO TREND INVOLVING THIS LOT NUMBER. NO ASSIGNABLE ROOT CAUSE COULD BE IDENTIFIED AND THERE WAS NO EVIDENCE TO SUPPORT THAT THE DEVICE DID NOT MEET THE SPECIFICATIONS. COMPLAINT TRENDS WILL BE CONTINUED TO BE MONITORED. THIS REPORT REMAINS REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON 17-AUG-2012 FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM (B)(6). THE MEDICAL HISTORY OF THE CONSUMER AND THE CONCOMITANT MEDICATION WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O B TAMPONS SUPER ABSORBENCY, VAGINALLY FOR MENSTRUATION (LOT NUMBER 2851M4072, EXPIRATION DATE AND FREQUENCY UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, SHE NOTICED THAT THE STRINGS WERE MISSING FROM THREE OF THE TAMPONS WHILE USING AND IT WAS AWKWARD TO GET TAMPONS OUT. SHE ALSO STATED THAT THE DEVICE DID NOT ABSORB PROPERLY. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT IS CONSIDERED AS REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O B TAMPONS SUPER ABSORBENCY TAMPON HEB MONTREAL SAN PRO 6260030102 2851M4072

    Patients

    Seq Age Sex Outcome Treatment
    1