BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7043722 · Received November 17, 2017

    Report

    Report Number
    2951250-2017-06803
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    September 1, 2013
    Report Date
    August 7, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN / PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037, 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SHOULDER OPERATION (2017) IN 2016. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CELEXA. CONCURRENT CONDITIONS INCLUDED OBESITY, PLATELET DYSFUNCTION, FIBROCYSTIC BREAST, ADENOMYOSIS, LEIOMYOMA NOS, VAGINAL BLEEDING, ABDOMINAL PAIN, URINARY FREQUENCY, SINUS DISORDER AND FIBROCYSTIC BREAST DISEASE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN APRIL 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). IN SEPTEMBER 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN APRIL 2015, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"). IN SEPTEMBER 2016, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND SALPINGECTOMY AND LAPAROSCOPY)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, WEIGHT INCREASED, MIGRAINE AND NAUSEA HAD RESOLVED AND THE ANXIETY AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, HEADACHE, MIGRAINE, NAUSEA, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TRAILING COIL LEFT: 03, TRAILING COILS RIGHT 06. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.9 KG/SQM. HYSTEROSALPINGOGRAM - ON 9-JAN-2013: TOTAL BILATERAL OCCLUSION . PELVIC PAIN, LOT NUMBER: 882191 , MANUFACTURE DATE: 2011/07 , EXPIRATION DATE: 2014/07 . LOT NUMBER: 893037 , MANUFACTURE DATE: 2011/08, EXPIRATION DATE: 2014/08 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-JUL-2018: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN / PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037,882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SHOULDER OPERATION ((B)(6)) IN (B)(6). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CELEXA. CONCURRENT CONDITIONS INCLUDED OBESITY, PLATELET DYSFUNCTION, FIBROCYSTIC BREAST, ADENOMYOSIS, LEIOMYOMA, VAGINAL BLEEDING, ABDOMINAL PAIN, URINARY FREQUENCY, SINUS DISORDER AND FIBROCYSTIC BREAST DISEASE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2015, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND SALPINGECTOMY AND LAPAROSCOPY)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, WEIGHT INCREASED, MIGRAINE AND NAUSEA HAD RESOLVED AND THE ANXIETY AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, HEADACHE, MIGRAINE, NAUSEA, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TRAILING COIL LEFT: 03, TRAILING COILS RIGHT 06. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. PELVIC PAIN, MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-JUN-2018: PFS RECEIVED - NEW EVENT "ANXIETY, MIGRAINES, HEADACHES, NAUSEA" WERE ADDED. LOT NUMBER WAS ADDED. HISTORICAL AND CONCOMITANT CONDITIONS WERE ADDED. NEW REPORTER WERE ADDED. LAB DATA WAS ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT INCIDENT NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819498 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893037, 882191

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R