BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10492862 · Received September 4, 2020

    Report

    Report Number
    2951250-2020-13789
    Event Type
    Injury
    Date Received
    September 4, 2020
    Date of Event
    June 1, 2013
    Report Date
    October 6, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871978) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY, DYSFUNCTIONAL UTERINE BLEEDING, ENDOMETRIAL ABLATION AND ABDOMINAL ADHESIONS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: SEASONIQUE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), 11 MONTHS 23 DAYS AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, VAGINAL HAEMORRHAGE, VAGINAL DISCHARGE, MOOD SWINGS, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, FATIGUE, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 227 LBS. NUMBER OF COIL S: LEFT : 3, NUMBER OF COILS: RIGHT: 4. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. LOT NUMBER: 871978. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-SEP-2020: PFS AND MR RECEIVED. REPORTER INFORMATION, LOT NUMBER, LAB DATA, MEDICAL HISTORY ADDED. EVENT MEDICAL DEVICE REMOVAL UPDATED TO EVENT PELVIC PAIN. EVENTS: ABDOMINAL PAIN, BACK PAIN, HORMONAL CHANGES DESCRIBE: MOOD SWINGS, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), DYSMENORRHEA (CRAMPING), VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871978) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY, DYSFUNCTIONAL UTERINE BLEEDING, ENDOMETRIAL ABLATION AND ABDOMINAL ADHESIONS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: SEASONIQUE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), 11 MONTHS 23 DAYS AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, VAGINAL HAEMORRHAGE, VAGINAL DISCHARGE, MOOD SWINGS, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, FATIGUE, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 227 LBS. NUMBER OF COIL S: LEFT : 3, NUMBER OF COILS: RIGHT: 4. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. LOT NUMBER: 871978. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-OCT-2020: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-SEP-2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957502 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 871978 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R