BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 6025861 · Received October 13, 2016

    Report

    Report Number
    2951250-2016-02184
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Report Date
    November 21, 2016
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT (PTC) RECEIVED ON 20-OCT-2016: THIS ADVERSE EVENT REPORT IS RELATED TO A PTC AND THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS (B)(4). NO SAMPLE AVAILABLE FOR THIS INVESTIGATION. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENT CANNOT BE TOTALLY EXCLUDED. THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. FOLLOW UP 26-OCT-2016: DESPITE FOLLOW UP ATTEMPTS, NO RESPONSE WAS RECEIVED FROM PATIENT. NO NEW CLINICAL INFORMATION WAS PROVIDED. NCA REFERENCE NUMBER FROM HEALTH AUTHORITY WAS ADDED, (B)(4). THE LIST OF SIMILAR CASES CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 27-OCT-2016 FOR THE FOLLOWING MEDDRA PREFERRED TERM: MEDICAL DEVICE REMOVAL. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 432 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS NON-MEDICALLY CONFIRMED AND POTENTIAL LEGAL CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND AFTER AN UNSPECIFIED TIME HAD THE XENOBIOTIC MATERIAL REMOVED. THIS EVENT IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THE PRESENT CASE, LIMITED INFORMATION WAS PROVIDED. THE EXACT REASON FOR DEVICE REMOVAL WAS NOT SPECIFIED. DESPITE THE LACK OF DETAILS FOR A COMPREHENSIVE CAUSALITY ASSESSMENT, CONSIDERING ESSURE REMOVAL WAS REQUIRED, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED AND THIS CASE WAS REGARDED AS INCIDENT. NO SAMPLE AVAILABLE FOR THIS INVESTIGATION AND NO VALID LOT NUMBER. THEREFORE, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO FURTHER INFORMATION COULD BE OBTAINED.

    Additional Manufacturer Narrative · 1

    FOLLOW UP 26-OCT-2016: DESPITE FOLLOW UP ATTEMPTS, NO RESPONSE WAS RECEIVED FROM PATIENT. NO NEW CLINICAL INFORMATION WAS PROVIDED. (B)(4). THE LIST OF SIMILAR CASES CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 27-OCT-2016 FOR THE FOLLOWING MEDDRA PREFERRED TERM: MEDICAL DEVICE REMOVAL. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 432 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS NON-MEDICALLY CONFIRMED AND POTENTIAL LEGAL CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND AFTER AN UNSPECIFIED TIME HAD THE XENOBIOTIC MATERIAL REMOVED. THIS EVENT IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THE PRESENT CASE, LIMITED INFORMATION WAS PROVIDED. THE EXACT REASON FOR DEVICE REMOVAL WAS NOT SPECIFIED. DESPITE THE LACK OF DETAILS FOR A COMPREHENSIVE CAUSALITY ASSESSMENT, CONSIDERING ESSURE REMOVAL WAS REQUIRED, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED AND THIS CASE WAS REGARDED AS INCIDENT. NO SAMPLE AVAILABLE FOR THIS INVESTIGATION AND NO VALID LOT NUMBER. THEREFORE, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO FURTHER INFORMATION COULD BE OBTAINED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM AN ADULT (>=18Y & <65Y) FEMALE CONSUMER IN (B)(6) ON 16-SEP-2016 WHO HAD ESSURE (ESS205) (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN 2005/2006. INITIAL CASE RECEIVED FROM A CONSUMER VIA LETTER IN WHICH SHE HOLDS BAYER LIABLE FOR THE DAMAGE CAUSED. TEN YEARS AGO IN 2005/2006 THE CONSUMER UNDERWENT A MEDICAL TREATMENT IN THE HOSPITAL, KNOWN AS THE ESSURE STERILIZATION METHOD. AFTER THIS TREATMENT SEVERAL PHYSICAL COMPLAINTS DEVELOPED. IN THE MEANTIME SHE HAS HAD FOLLOW-UP TREATMENTS AND THE XENOBIOTIC MATERIAL HAS BEEN REMOVED. BECAUSE OF THE COMPLAINTS CONSUMER IS BEING IMPEDED IN HER NORMAL DAILY FUNCTIONING AND SHE IS SUFFERING FROM INJURY. FOLLOW-UP INFORMATION IS EXPECTED. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS NON-MEDICALLY CONFIRMED AND POTENTIAL LEGAL CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND AFTER AN UNSPECIFIED TIME HAD THE XENOBIOTIC MATERIAL REMOVED. THIS EVENT IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THE PRESENT CASE, LIMITED INFORMATION WAS PROVIDED. THE EXACT REASON FOR DEVICE REMOVAL WAS NOT SPECIFIED. DESPITE THE LACK OF DETAILS FOR A COMPREHENSIVE CAUSALITY ASSESSMENT, CONSIDERING ESSURE REMOVAL WAS REQUIRED, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED AND THIS CASE WAS REGARDED AS INCIDENT. A PRODUCT TECHNICAL ANALYSIS AND FURTHER INFORMATION ARE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680083 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R