BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4616829 · Received March 19, 2015

    Report

    Report Number
    2951250-2015-00200
    Event Type
    Injury
    Date Received
    March 19, 2015
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    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

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

    Description of Event or Problem · 1

    THIS IS A SOLICITED CASE REPORT RECEIVED FROM A FEMALE CONSUMER OF UNSPECIFIED AGE VIA SOCIAL MEDIA IN (B)(6) ON (B)(6) 2015. SHE WAS INVOLVED (B)(6). CONSUMER REPORTED SHE RECENTLY HAD THE ESSURE PROCEDURE AND THEY HAD TO PUSH THE LEFT COIL IN FURTHER. AFTER AN INFECTION AND TAKING 3 LOTS OF ANTIBIOTICS SHE IS STILL IN PAIN; SHE IS ON TRAMADOL AND PARACETAMOL WHICH ONLY DULLS THE PAIN. PTC INVESTIGATION RESULT RECEIVED ON (B)(4) 2015. (B)(4). FINAL ASSESSMENT: 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. 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. NO NEW FAILURE MODE HAS BEEN IDENTIFIED. 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 BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE (B)(4) DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. 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. THE LIST OF SIMILAR CASES CONTAINS REPORTS WITH SIMILAR EVENTS CODED IN (B)(4). IT INCLUDES RECENT CASES RECEIVED BY BAYER PHARMA AND OLDER CASES RECEIVED FROM THE PREVIOUS OWNER OF THE ESSURE PRODUCT (CONCEPTUS). THESE LEGACY REPORTS HAVE BEEN RE-CODED ACCORDING TO BAYER PHARMA STANDARDS. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(4) 2015 FOR THE FOLLOWING (B)(4) PREFERRED TERM: PELVIC INFECTION. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 5 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. THIS INCLUDES CONSIDERATION OF THE LEGACY CASES IN SAFETY ANALYSES. THE CUMULATIVE REVIEW OF THE REPORTS HAS NOT YIELDED ANY NEW SAFETY SIGNAL. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SOCIAL MEDIA CASE REPORT, REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED AN INFECTION; SHE WAS TAKING 3 LOTS OF ANTIBIOTICS. THE REPORTED EVENT, INTERPRETED AS PELVIC INFECTION, WAS CONSIDERED SERIOUS AS MEDICALLY SIGNIFICANT AND IS LISTED ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION. ESSURE MICRO-INSERTS ARE SUPPLIED STERILE AND PLACED UNDER HYSTEROSCOPIC GUIDANCE IN THE PROXIMAL FALLOPIAN TUBE. HOWEVER, AS WITH ALL TRANS-CERVICAL PROCEDURES, THIS MICRO-INSERT PLACEMENT CAN CAUSE PELVIC INFECTION DUE TO BACTERIAL CONTAMINATION DURING INSERTION. IN THIS PARTICULAR CASE, LIMITED INFORMATION WAS PROVIDED; HOWEVER, AS CONSUMER STATED ESSURE INSERTION WAS RECENT, A CAUSAL RELATIONSHIP BETWEEN THE REPORTED PELVIC INFECTION AND ESSURE PROCEDURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS AN INCIDENT SINCE A MEDICAL INTERVENTION (ANTIBIOTIC THERAPY) WAS REQUIRED AS EVENT'S TREATMENT. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. A PRODUCT TECHNICAL ANALYSIS WAS PERFORMED AND CONCLUDED THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. NO FURTHER INFORMATION WILL BE REQUESTED SINCE THIS IS A SOCIAL MEDIA CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187935 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R