BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5366129 · Received January 14, 2016

    Report

    Report Number
    2951250-2016-00014
    Event Type
    Injury
    Date Received
    January 14, 2016
    Date of Event
    June 1, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY SAFETY EVALUATION RECEIVED ON 26-APR-2016: PTC GLOBAL NUMBER (B)(4). BATCH NUMBER 822376. MANUFACTURING DATE: JAN-2011 AND EXPIRATION DATE: JAN-2014. FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. IN THIS CASE, NO PRODUCT WAS RETURNED. 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. BASED ON THE AVAILABLE INFORMATION NO PRODUCT QUALITY DEFECT WAS CONFIRMED. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS AND MEDICALLY CONFIRMED CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED PELVIC PAIN. PHYSICIAN WILL PERFORM A HYSTERECTOMY. THIS EVENT IS SERIOUS DUE TO MEDICAL IMPORTANCE AND REQUIRED INTERVENTION AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING PELVIC PAIN MAY OCCUR DURING ESSURE USE AND THE TEMPORAL RELATIONSHIP, CAUSAL RELATIONSHIP BETWEEN REPORTED EVENT AND ESSURE USE CANNOT BE EXCLUDED AND SINCE AN INTERVENTION WILL BE PERFORMED, THIS CASE IS REGARDED AS INCIDENT. BASED ON THE AVAILABLE INFORMATION NO PRODUCT QUALITY DEFECT WAS CONFIRMED.

    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 SPONTANEOUS CASE REPORT RECEIVED FROM A PHYSICIAN IN UNITED STATES ON 16-DEC-2015 WHICH REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN (B)(6) 2011, LOT NUMBER 822376, FOR CONTRACEPTION. ADDITIONAL INFORMATION RECEIVED ON 17-DEC-2015. IN (B)(6) 2015 SHE STARTED TO EXPERIENCED PELVIC PAIN AND IRREGULAR MENSTRUAL BLEEDING. DOCTOR WILL PERFORM A HYSTERECTOMY. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS AND MEDICALLY CONFIRMED CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED PELVIC PAIN. PHYSICIAN WILL PERFORM A HYSTERECTOMY. THIS EVENT IS SERIOUS DUE TO MEDICAL IMPORTANCE AND REQUIRED INTERVENTION AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING PELVIC PAIN MAY OCCUR DURING ESSURE USE AND THE TEMPORAL RELATIONSHIP, CAUSAL RELATIONSHIP BETWEEN REPORTED EVENT AND ESSURE USE CANNOT BE EXCLUDED AND SINCE AN INTERVENTION WILL BE PERFORMED, THIS CASE IS REGARDED AS INCIDENT. FURTHER INFORMATION (DATE OF INTERVENTION AND OUTCOME) AND PTC RESULTS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25239 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 822376

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R