BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7000804 · Received November 3, 2017

    Report

    Report Number
    2951250-2017-06016
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    August 1, 2014
    Report Date
    August 27, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN") IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871772-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL. CONCURRENT CONDITIONS INCLUDED MENORRHAGIA, MUSCLE CRAMPS, NAUSEA, DIZZINESS, DIARRHEA, FEVER, BICORNUATE UTERUS AND URINARY TRACT INFECTION (ACUTE.). CONCOMITANT PRODUCTS INCLUDED CO-TRIMOXAZOLE (BACTRIM), IBUPROFEN FROM 2014 TO 2015, LORAZEPAM, LORAZEPAM (ATIVAN) FROM 2012 TO 2015, NORLESTRIN FE (LOESTRIN FE) FROM (B)(6) 2014 TO (B)(6) 2014, PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM) AND PROCET (ACETAMINOPHEN W/HYDROCODONE). IN 2014, THE PATIENT EXPERIENCED VISUAL IMPAIRMENT ("VISION DECREASED RAPIDLY"). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS / HAIR LOSS"), FATIGUE ("FATIGUE / FATIGUE"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2014, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE CRAMPING / LOWER LEFT QUADRANT"), PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (A TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY TO REMOVE ESSURE DEVICES). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, PROCEDURAL PAIN, ALOPECIA, FATIGUE AND WEIGHT INCREASED WAS RESOLVING, THE DEPRESSION, ANXIETY, HEADACHE AND NAUSEA HAD RESOLVED AND THE MIGRAINE AND VISUAL IMPAIRMENT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, DEPRESSION, FATIGUE, HEADACHE, MIGRAINE, NAUSEA, PELVIC PAIN, PROCEDURAL PAIN, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.4 KG/SQM. HYSTEROSALPINGOGRAM ON (B)(6) 2014: FULL OCCLUSION OF FALLOPIAN TUBES. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, LOWER LEFT QUADRANT, FATIGUE, NAUSEA". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-AUG-2018: UPDATE OF INFORMATION (BATCH IS INVALID). INCIDENT: NO VALID 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN") IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871772) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL. CONCURRENT CONDITIONS INCLUDED MENORRHAGIA, MUSCLE CRAMPS, NAUSEA, DIZZINESS, DIARRHEA, FEVER, BICORNUATE UTERUS AND URINARY TRACT INFECTION (ACUTE.). CONCOMITANT PRODUCTS INCLUDED CO-TRIMOXAZOLE (BACTRIM), IBUPROFEN FROM 2014 TO 2015, LORAZEPAM, LORAZEPAM (ATIVAN) FROM 2012 TO 2015, NORLESTRIN FE (LOESTRIN FE) FROM (B)(6) 2014 TO (B)(6) 2014, PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM) AND PROCET (ACETAMINOPHEN W/HYDROCODONE). IN 2014, THE PATIENT EXPERIENCED VISUAL IMPAIRMENT ("VISION DECREASED RAPIDLY"). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS / HAIR LOSS"), FATIGUE ("FATIGUE / FATIGUE"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2014, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE CRAMPING / LOWER LEFT QUADRANT"), PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (A TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY TO REMOVE ESSURE DEVICES). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, PROCEDURAL PAIN, ALOPECIA, FATIGUE AND WEIGHT INCREASED WAS RESOLVING, THE DEPRESSION, ANXIETY, HEADACHE AND NAUSEA HAD RESOLVED AND THE MIGRAINE AND VISUAL IMPAIRMENT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, DEPRESSION, FATIGUE, HEADACHE, MIGRAINE, NAUSEA, PELVIC PAIN, PROCEDURAL PAIN, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: FULL OCCLUSION OF FALLOPIAN TUBES. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, LOWER LEFT QUADRANT, FATIGUE, NAUSEA". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-JUN-2018: MEDICAL RECORD WAS RECEIVED REPORTER INFORMATION, CONCOMITANT DISEASE, LOT NUMBER WAS ADDED FROM MR. 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 ("SEVERE PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"), ALOPECIA ("HAIR LOSS"), FATIGUE ("FATIGUE") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (A TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY TO REMOVE ESSURE DEVICES). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, PROCEDURAL PAIN, ALOPECIA, FATIGUE AND WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, FATIGUE, PELVIC PAIN, PROCEDURAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: FULL OCCLUSION OF FALLOPIAN TUBES 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
    778943 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 871772-INVALID

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| R ACETAMINOPHEN W/HYDROCODONE| ACETAMINOPHEN W/HYDROCODONE| ATIVAN| ATIVAN| BACTRIM| BACTRIM| IBUPROFEN| IBUPROFEN| LOESTRIN FE| LOESTRIN FE| LORAZEPAM| LORAZEPAM| PYRIDIUM| PYRIDIUM