BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B. ULTRA ABSORBENCY TAMPONS

    MDR report key: 2970843 · Received February 21, 2013

    Report

    Report Number
    8022269-2013-00011
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 3, 2013
    Manufacturer
    MONTREAL SAN PRO
    Product Code
    HEB
    PMA / PMN Number
    K974629
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(4) 2013. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(4) 2013. 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. THE MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2013, THE CONSUMER STARTED USING O.B. UNSPECIFIED, VAGINALLY, FOR MENSTRUATION (LOT NUMBER 1242M5983, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER SEVEN DAYS, SHE FELT DISCOMFORT IN VAGINA, AFTER WHICH, SHE NOTICED THAT A PLASTIC UPPER PART OF THE DEVICE WRAPPER WAS INSIDE HER VAGINA. SHE STATED THAT SHE DID NOT KNOW HOW LONG THAT PLASTIC PART WAS INSIDE HER VAGINA AND THAT PART WAS FILLED WITH OLD BLOOD WHEN SHE TOOK IT OUT BUT SHE DID NOT HAVE ANY MEDICAL ISSUES FROM IT. SHE STATED THAT SHE DID NOT USE TAMPON FOR AT LEAST 24 HOURS. SHE ALSO STATED THAT THE CLEAR PLASTIC PART OF THE DEVICE WAS ALMOST IMPOSSIBLE TO SEE, AND TENDS TO COLLECT STATIC AND CLING AND COULD VERY EASILY REMAIN ON THE DEVICE BY MISTAKE. THE OUTCOME OF THE EVENT DISCOMFORT WAS UNKNOWN. THIS REPORT HAD NON-SERIOUS EVENT. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. 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) 2013 FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2013, THE CONSUMER STARTED USING O.B. UNSPECIFIED, VAGINALLY, FOR MENSTRUATION (LOT NUMBER 1242M5983, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER SEVEN DAYS, SHE FELT DISCOMFORT IN VAGINA, AFTER WHICH, SHE NOTICED THAT A PLASTIC UPPER PART OF THE DEVICE WRAPPER WAS INSIDE HER VAGINA. SHE STATED THAT SHE DID NOT KNOW HOW LONG THAT PLASTIC PART WAS INSIDE HER VAGINA AND THAT PART WAS FILLED WITH OLD BLOOD WHEN SHE TOOK IT OUT BUT SHE DID NOT HAVE ANY MEDICAL ISSUES FROM IT. SHE STATED THAT SHE DID NOT USE TAMPON FOR AT LEAST 24 HOURS. SHE ALSO STATED THAT THE CLEAR PLASTIC PART OF THE DEVICE WAS ALMOST IMPOSSIBLE TO SEE, AND TENDS TO COLLECT STATIC AND CLING AND COULD VERY EASILY REMAIN ON THE DEVICE BY MISTAKE. THE OUTCOME OF THE EVENT DISCOMFORT WAS UNKNOWN. THIS REPORT HAD NON-SERIOUS EVENT. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 DEVICE NAME WAS UPDATED FROM O.B. UNSPECIFIED TO O.B. ULTRA ABSORBENCY TAMPONS. THE CONSUMER PROVIDED A VALID LOT NUMBER WITH THE COMPLAINT. THE MANUFACTURER HAD NOT RECEIVED A RETURNED SAMPLE AS OF (B)(4) 2013. A MANUFACTURING AND PACKAGING 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 MAY BE ASSOCIATED TO THIS TYPE OF COMPLAINT WAS OBSERVED. A VISUAL INSPECTION OF THE RETAIN SAMPLE CONFIRMED THAT NO NONCONFORMANCE OR MANUFACTURING DEFECTS RELATED TO THIS COMPLAINT WERE PRESENT. A REVIEW OF THE HISTORY OF CHANGES PERFORMED ON THE PRODUCT AND PROCESS IN THE O.B. DEPARTMENT AND REVEALED NO EVIDENCE TO SUPPORT THAT THE CHANGES MADE ARE RELATED TO THIS COMPLAINT. THIS COMPLAINT WAS MOSTLY DUE TO A HUMAN ERROR AND NOT TO A PRODUCT DEFECT. THE ANALYST CONFIRMED THAT NO TREND WAS OBSERVED ON WRAPPER STUCK IN BODY OR ON HUMAN ERROR AS A ROOT CAUSE FOR STUCK IN BODY ISSUES. BASED ON THE INVESTIGATION RESULTS RELATED TO MANUFACTURING REVIEW AND CHANGE REVIEW, DUE TO LACK OF A COMPLAINT SAMPLE AND THE ABSENCE OF ADVERSE TREND, NO ASSIGNABLE ROOT CAUSE COULD BE IDENTIFIED. THERE WAS NO EVIDENCE TO SUPPORT THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS 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
    76948 O.B. ULTRA ABSORBENCY TAMPONS TAMPON HEB MONTREAL SAN PRO OBGENLUS 1242M5983

    Patients

    Seq Age Sex Outcome Treatment
    1