BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6039808 · Received October 19, 2016

    Report

    Report Number
    2951250-2016-02234
    Event Type
    Injury
    Date Received
    October 19, 2016
    Report Date
    November 17, 2016
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP INFORMATION RECEIVED ON 25-OCT-2016: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT (PTC). THIS ADVERSE EVENT REPORT IS RELATED TO A PTC AND THE BAYER (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 IS A KNOWN, POSSIBLE, UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFECT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION AND A REVIEW OF SIMILAR AE CASE REPORT ARE APPLICABLE. THE LIST OF DEVICE SIMILAR INCIDENTS 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 28-OCT-2016 FOR THE FOLLOWING MEDDRA PREFERRED TERM: PELVIC PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 1734 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 SOLICITED NON-MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD 2 YEARS OF PAIN (INTERPRETED AS PELVIC PAIN). SHE UNDERWENT A HYSTERECTOMY. THIS EVENT IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. AFTER ESSURE INSERTION, PELVIC PAIN MAY OCCUR. IN THE PRESENT CASE, LIMITED INFORMATION WAS PROVIDED. CONSUMER´S MEDICAL HISTORY AND CONCOMITANT CONDITIONS WERE NOT MENTIONED. THE EXACT INTERVAL BETWEEN ESSURE INSERTION AND PAIN ONSET WAS NOT SPECIFIED. GIVEN THE NATURE OF THE REPORTED EVENT AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE SURGICAL INTERVENTION WAS REQUIRED. ACCORDING TO PRODUCT TECHNICAL ANALYSIS, SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION AND A REVIEW OF SIMILAR AE CASE REPORT ARE APPLICABLE. FURTHER INFORMATION CANNOT BE OBTAINED, AS NO CONTACT DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    THIS IS A SOLICITED CASE REPORT RECEIVED FROM A CONSUMER`S FIANCEE IN (B)(6) ON (B)(6) 2016 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO WAS INVOLVED IN A MARKET RESEARCH ACTIVITY, STUDY NUMBER: (B)(6). STUDY DESCRIPTION: ESSURE GENERIC MARKET RESEARCH PROGRAM. THE REPORTER STATED THAT ESSURE HAD CAUSED HIS FIANCEE 2 YEARS OF PAIN, JOB LOSS, AND THE NEED FOR A HYSTERECTOMY. FOLLOW-UP INFORMATION RECEIVED ON 28-SEP-2016: THE HEALTH AUTHORITY REFERENCE NUMBER FOR THIS CASE IS: (B)(6). COMPANY CAUSALITY COMMENT: THIS SOLICITED NON-MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD 2 YEARS OF PAIN (INTERPRETED AS PELVIC PAIN). SHE UNDERWENT A HYSTERECTOMY. THIS EVENT IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. AFTER ESSURE INSERTION, PELVIC PAIN MAY OCCUR. IN THE PRESENT CASE, LIMITED INFORMATION WAS PROVIDED. CONSUMER'S MEDICAL HISTORY AND CONCOMITANT CONDITIONS WERE NOT MENTIONED. THE EXACT INTERVAL BETWEEN ESSURE INSERTION AND PAIN ONSET WAS NOT SPECIFIED. GIVEN THE NATURE OF THE REPORTED EVENT AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE SURGICAL INTERVENTION WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS IS EXPECTED. FURTHER INFORMATION CANNOT BE OBTAINED, AS NO CONTACT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691865 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER HEALTHCARE LLC ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R