BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B. SILK EASE PRODUCTS

    MDR report key: 3133265 · Received May 29, 2013

    Report

    Report Number
    8022269-2013-00045
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 14, 2013
    Manufacturer
    MONTREAL SAN PRO
    Product Code
    HEB
    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) 2013 FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (OB SILK EASE NON-APPLICATOR 20S). THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL FOLLOW UP INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED (B)(4) 2013 FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (OB SILK EASE NON-APPLICATOR 20S). 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)(4) 2013 FROM A (B)(6) CAUCASIAN 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. SILK EASE PRODUCTS ONE TAMPON AT A TIME, VAGINALLY FOR MENSTRUATION (LOT NUMBER AND 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 STRING BREAKAGE, SHE WAS ABLE TO REMOVE THE TAMPONS ON BOTH OCCASIONS. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A (B)(6) CAUCASIAN 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. SILK EASE PRODUCTS ONE TAMPON AT A TIME, VAGINALLY FOR MENSTRUATION (LOT NUMBER AND 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 STRING BREAKAGE, SHE WAS ABLE TO REMOVE THE TAMPONS ON BOTH OCCASIONS. 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. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. THE CONSUMER DID NOT PROVIDE A LOT NUMBER WITH THE COMPLAINT. THE RETURNED SAMPLE WAS NOT RECEIVED AS OF 06-JUN-2013. REVIEW OF THE DATA ASSOCIATED WITH EACH COMPLAINT FOUND NO ADVERSE TRENDS. UPON REVIEW IN THE OB DEPARTMENT OVER THE PERIOD OF 07-JUN-2011 TO 07-JUN-2013 FOUND A TOTAL OF 3 NC'S WERE RECORDED FOR DEFECTS RELATED TO STRING ISSUES. UPON REVIEW OF THE CHANGES PERFORMED ON THE PRODUCT AND PROCESS IN THE O.B. DEPARTMENT OVER THE PERIOD OF 06-JUN-2011 AND 06-JUN-2013. IN THIS TIME PERIOD, THE ONLY SIGNIFICANT CHANGE THAT WAS MADE TO THE STRING WAS CHANGE OF THE SUPPLIER LOCATION. BASED ON THE INVESTIGATION RESULTS, NO ASSIGNABLE CAUSE WAS IDENTIFIED. COMPLAINT TRENDS WOULD BE CONTINUED TO BE MONITORED. THE 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
    236609 O.B. SILK EASE PRODUCTS TAMPON HEB MONTREAL SAN PRO 8004139600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1