BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5034293 · Received August 27, 2015

    Report

    Report Number
    2951250-2015-00648
    Event Type
    Injury
    Date Received
    August 27, 2015
    Report Date
    January 20, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS

    Additional Manufacturer Narrative · 1

    FOLLOW UP INFORMATION RECEIVED ON 20-OCT-2015: THIS FOLLOW UP HAS BEEN IDENTIFIED DURING MONITORING OF POSTINGS ON AN FDA HOSTED DOCKET WEBSITE, WHICH HAS BEEN ESTABLISHED IN PREPARATION OF A PUBLIC FDA ADVISORY COMMITTEE MEETING, WHICH TOOK PLACE IN SEPTEMBER 2015 ((B)(4)). CONSUMER REPORTED THAT SHE HAD ESSURE INSERTED IN AUG-2011 FOR PERMANENT STERILIZATION. SINCE INSERTION SHE EXPERIENCED EXTREME ABDOMINAL PAINS. SHE ALSO EXPERIENCED EXTREME WEIGHT GAIN AND THINNING HAIR. ON (B)(6)-2014 SHE HAD A SALPINGECTOMYPERFORMED. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED EXTREME PAIN IN MY LOWER ABDOMEN, IT WAS MORE PROMINENT ON THE RIGHT SIDE BUT STILL AFFECTED HER LEFT AS WELL. THIS EVENT WAS CONSIDERED SERIOUS DUE TO MEDICAL IMPORTANCE AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THIS CASE, CONSUMER UNDERWENT UNSPECIFIED TESTS, ULTRASOUNDS AND EXAMS AND NOTHING WAS FOUND. CONSUMER HAD HER TUBES AND ESSURE DEVICES REMOVED. CONSIDERING THE EVENT NATURE, A CAUSAL RELATIONSHIP BETWEEN THIS EVENT AND SUSPECT INSERT CANNOT BE EXCLUDED. DUE TO PERFORMED SURGICAL INTERVENTION, THIS CASE WAS REGARDED AS INCIDENT. THE PRODUCT TECHNICAL ANALYSIS CONCLUDED THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. NO FURTHER INFORMATION IS EXPECTED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER VIA REGULATORY AUTHORITY (CASE# MW5043357) IN UNITED STATES ON 03-AUG-2015 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) LOT NUMBER 844600 INSERTED ON (B)(6) 2011. A FEW MONTHS AFTER GETTING THE IMPLANTS, CONSUMER STARTED EXPERIENCING EXTREME PAIN IN HER LOWER ABDOMEN. IT WAS MORE PROMINENT ON THE RIGHT HAND SIDE, BUT STILL AFFECTED HER LEFT AS WELL. SHE WOULD HAVE TO CALL IN TO WORK AT TIMES, AS SHE COULD BARELY GET OUT OF BED, LET ALONE CARE FOR HER SMALL CHILD IN SUCH PAIN. UNSPECIFIED TESTS, ULTRASOUNDS AND EXAMS WERE PERFORMED AND NOTHING WAS EVER THE CAUSE. HER DOCTOR THOUGHT THERE MAY HAVE BEEN CYSTS THAT WERE CAUSING THE PAINS, BUT NOTHING WAS FOUND DURING TESTS AND PROCEDURES. ESSURE WAS REMOVED ON (B)(6) 2014. SINCE REMOVAL OF HER TUBES AND THE ESSURE DEVICES, SHE HAS HAD NONE OF THE SAME PAINS OR DISCOMFORT. PTC INVESTIGATION RESULT WAS RECEIVED ON 11-AUG-2015. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: (B)(4). FINAL ASSESSMENT: LOT NUMBER 844600; PRODUCTION DATE: 3/2011; EXPIRATION DATE: 3/2014. SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. IN THIS CASE, WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE REPORTED ADVERSE EVENT IS A KNOWN POSSIBLE UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. NO BATCH SIGNAL COULD BE IDENTIFIED. THE BATCH DOCUMENTATION OF THE REPORTED BATCH WAS REVIEWED. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED EXTREME PAIN IN MY LOWER ABDOMEN, IT WAS MORE PROMINENT ON THE RIGHT SIDE BUT STILL AFFECTED HER LEFT AS WELL. THIS EVENT WAS CONSIDERED SERIOUS DUE TO MEDICAL IMPORTANCE AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THIS CASE, CONSUMER UNDERWENT UNSPECIFIED TESTS, ULTRASOUNDS AND EXAMS AND NOTHING WAS FOUND. CONSUMER HAD HER TUBES AND ESSURE DEVICES REMOVED. CONSIDERING THE EVENT NATURE, A CAUSAL RELATIONSHIP BETWEEN THIS EVENT AND SUSPECT INSERT CANNOT BE EXCLUDED. DUE TO PERFORMED SURGICAL INTERVENTION, THIS CASE WAS REGARDED AS INCIDENT. THE PRODUCT TECHNICAL ANALYSIS CONCLUDED THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. FURTHER INFORMATION IS BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567126 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 844600

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R