BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B TAMPONS PROCOMFORT REGULAR

    MDR report key: 3131657 · Received May 29, 2013

    Report

    Report Number
    8022269-2013-00044
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 14, 2013
    Manufacturer
    MONTREAL SAN PRO
    Product Code
    HEB
    PMA / PMN Number
    K023789
    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) FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (OB PROCOMFORT REGULAR 18S). THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL FOLLOW UP INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED (B)(6) 2013 FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (OB PROCOMFORT REGULAR 18S). 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) 2013 FROM (B)(6) FEMALE CONSUMER REPORTING FOR SELF FROM (B)(6). THE CONSUMER DID NOT HAVE ANY KNOWN MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O.B. TAMPONS PROCOMFORT REGULAR ONE TAMPON AT A TIME, VAGINALLY FOR MENSTRUATION (LOT NUMBER 1812M6569, EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, WHEN SHE TRIED TO REMOVE THE TAMPON THE STRING BROKE OFF AND THE ENTIRE TAMPON GOT STUCK IN HER VAGINA. SHE STATED THAT SHE EXPERIENCED THE SAME ADVERSE EVENT WITH ANOTHER TAMPON. IN LESS THAN SIX HOURS OF TAMPON BREAKAGE, SHE WAS ABLE TO REMOVE BOTH THE TAMPONS. SHE STATED THAT SHE TRANSFERRED FEW O.B. SILK EASE TAMPONS INTO O.B. PROCOMFORT & APOS'S PACKAGING AND THREW AWAY O.B. SILK EASE & APOS'S BOX AS THERE WERE ONLY A FEW TAMPONS LEFT IN THE O.B. SILK EASE TAMPONS PACKAGE AS A RESULT OF WHICH SHE WAS UNSURE OF WHICH TAMPONS STRING BROKE OFF. AFTER AN UNSPECIFIED DURATION, SHE DISCONTINUED THE DEVICE. THIS REPORT WAS ASSESSED AS NON-SERIOUS. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013. THE CONSUMER PROVIDED A VALID LOT NUMBER WITH THE COMPLAINT. THE RETURNED SAMPLE WAS RECEIVED ON (B)(6) 2013. THE ANALYST PERFORMED A REVIEW OF THE DATA ASSOCIATED WITH COMPLAINT CATEGORIES AND FOUND NO LOT TREND AND NO SUBJECT CATEGORY TREND FOR THE PRODUCT FAMILY O.B. PROCOMFORT DIGITAL REGULAR CA. A REVIEW OF THE DATA ASSOCIATED WITH THE COMPLAINT FOUND NO LOT TREND AND NO SUBJECT CATEGORY TREND FOR THE PRODUCT FAMILY. A BATCH RECORD REVIEW WAS PERFORMED AND THE 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 MAY BE ASSOCIATED TO THIS TYPE OF COMPLAINT WAS OBSERVED. THE DEVICE MET THE SPECIFICATIONS. VISUAL INSPECTION OF THE RETAINED SAMPLE FOUND NO ANOMALIES RELATED TO THIS COMPLAINT. VISUAL INSPECTION OF THE RETURNED SAMPLE FOUND NO ISSUES. REVIEW OF THE HISTORY OF NON CONFORMANCES (NC) AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPAS) WAS RECORDED IN THE O.B. DEPARTMENT FOR THIS TAMPON FORMAT (GK) FOR LOT#1812M6569 OVER THE PERIOD OF (B)(6) 2011 UNTIL (B)(6) 2013. IN THIS TIME PERIOD, NO NC WAS RECORDED FOR DEFECTS RELATED TO THIS COMPLAINT. PROCESS OR FACILITY CHANGES FOUND NO ISSUES. BASED ON THE INVESTIGATION RESULTS, NO ASSIGNABLE CAUSE WAS IDENTIFIED. COMPLAINT TRENDS WOULD BE CONTINUED TO BE MONITORED. THIS REPORT REMAINS NON-SERIOUS. THIS REPORT REMAINS 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) FEMALE CONSUMER REPORTING FOR SELF FROM (B)(6). THE CONSUMER DID NOT HAVE ANY KNOWN MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O.B TAMPONS PROCOMFORT REGULAR ONE TAMPON AT A TIME, VAGINALLY FOR MENSTRUATION (LOT NUMBER 1812M6569, EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, WHEN SHE TRIED TO REMOVE THE TAMPON THE STRING BROKE OFF AND THE ENTIRE TAMPON GOT STUCK IN HER VAGINA. SHE STATED THAT SHE EXPERIENCED THE SAME ADVERSE EVENT WITH ANOTHER TAMPON. IN LESS THAN SIX HOURS OF TAMPON BREAKAGE, SHE WAS ABLE TO REMOVE BOTH THE TAMPONS. SHE STATED THAT SHE TRANSFERRED FEW O.B. SILK EASE TAMPONS INTO O.B. "PROCOMFORT'S" PACKAGING AND THREW AWAY O.B. SILK "EASE'S" BOX AS THERE WERE ONLY A FEW TAMPONS LEFT IN THE O.B. SILK EASE TAMPONS PACKAGE AS A RESULT OF WHICH SHE WAS UNSURE OF WHICH TAMPONS STRING BROKE OFF. AFTER AN UNSPECIFIED DURATION, SHE DISCONTINUED THE DEVICE. THIS REPORT WAS ASSESSED AS NON-SERIOUS. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234158 O.B TAMPONS PROCOMFORT REGULAR TAMPON HEB MONTREAL SAN PRO 8004180300 1812M6569

    Patients

    Seq Age Sex Outcome Treatment
    1