BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6142034 · Received December 2, 2016

    Report

    Report Number
    2951250-2016-02612
    Event Type
    Injury
    Date Received
    December 2, 2016
    Report Date
    January 4, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY-SAFETY EVALUATION OF PTC ((B)(4)) RECEIVED ON 07-DEC-2016 - : SAMPLE NOT AVAILABLE. 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. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, 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. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS LEGAL CASE REPORT REFERS TO (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHE PRESENTED ABDOMINAL PAIN, THEN AROUND SIX YEARS AFTER PLACEMENT SHE UNDERWENT SURGERY TO REMOVE ESSURE COILS. THE REPORTED EVENT IS SERIOUS DUE TO MEDICAL IMPORTANCE AND ANTICIPATED IN ESSURE'S REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, PELVIC, ABDOMINAL AND UNCHARACTERIZED PAIN MAY OCCUR. IN THIS SPECIFIC CASE, SHORTLY AFTER UNDERGOING THE ESSURE INSERTION CONSUMER HAD THE EVENT AND A SURGERY WAS NECESSARY TO REMOVE IT. CONSIDERING THE NATURE OF THE EVENT AND IN THE LACK OF ALTERNATIVE EXPLANATION, CAUSALITY CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. OTHER NON-SERIOUS EVENTS WERE REPORTED. NO SAMPLE AVAILABLE FOR THIS INVESTIGATION AND NO VALID LOT NUMBER. THEREFORE, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A LAWYER, ON BEHALF OF A PLAINTIFF IN UNITED STATES ON 08-NOV-2016 WHICH REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN (B)(6) 2009. SHORTLY AFTER UNDERGOING THE ESSURE PROCEDURE, AN HYSTEROSALPINGOGRAM TEST WAS PERFORMED AND SHOWED COILS WERE PROPERLY PLACED. HOWEVER, HER POST-PROCEDURE PERIOD HAS BEEN MARKED BY INCREASINGLY SEVERE PAIN AND DISCOMFORT, INCLUDING ABDOMINAL PAIN, MOOD SWINGS, AND CHRONIC FATIGUE. SHE NEVER EXPERIENCED ANY OF THESE CONDITIONS PRIOR TO UNDERGOING THE ESSURE PROCEDURE. SHE SUBSEQUENTLY SOUGHT TREATMENT FOR HER SYMPTOMS FROM HER PHYSICIAN, BUT WAS UNABLE TO RESOLVE THEM. ON (B)(6) 2015, SHE UNDERWENT SURGERY TO REMOVE HER ESSURE COILS. SHE WAS PREVENTED FROM PRACTICING AND ENJOYING THE ACTIVITIES OF DAILY LIFE SHE ENJOYED PRE-OPERATIVELY, AND SHE HAS OTHERWISE SUFFERED SERIOUS AND PERMANENT INJURIES. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS LEGAL CASE REPORT REFERS TO (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHE PRESENTED ABDOMINAL PAIN, THEN AROUND SIX YEARS AFTER PLACEMENT SHE UNDERWENT SURGERY TO REMOVE ESSURE COILS. THE REPORTED EVENT IS SERIOUS DUE TO MEDICAL IMPORTANCE AND ANTICIPATED IN ESSURE'S REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, PELVIC, ABDOMINAL AND UNCHARACTERIZED PAIN MAY OCCUR. IN THIS SPECIFIC CASE, SHORTLY AFTER UNDERGOING THE ESSURE INSERTION CONSUMER HAD THE EVENT AND A SURGERY WAS NECESSARY TO REMOVE IT. CONSIDERING THE NATURE OF THE EVENT AND IN THE LACK OF ALTERNATIVE EXPLANATION, CAUSALITY CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. OTHER NON-SERIOUS EVENTS WERE REPORTED. THE PRODUCT TECHNICAL ANALYSIS HAS BEEN SOUGHT. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792750 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R