ESSURE
Report
- Report Number
- 2951250-2017-08235
- Event Type
- Injury
- Date Received
- November 23, 2017
- Report Date
- June 7, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B40017) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CECLOR, DILAUDID AND YAZ. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED HYPERSENSITIVITY WITH DILAUDID; AND RASH WITH CECLOR. CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, OVARIAN CYST AND PARATUBAL CYST. 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), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPHINGECTOMY, HYSTEROSCOPY) AND SURGERY (D & C). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: LEFT FALLOPIAN TUBE- 5 TRAILING COILS, RIGHT TUBE- APPROXIMATELY 5 TRAILING COILS. SHE ALSO UNDERWENT CYSTECTOMY AND ENTEROLYSIS. DISCREPANCY NOTED IN LOT NUMBER (PFS VS. MR), AS PER MR ITS 840017. LAPAROSCOPY WITH RIGHT OVARIAN CYSTECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON (B)(6) 2014: NEGATIVE ON (B)(6) 2016 SURGICAL PATHOLOGY REPORT REVEALED, ENDOMETRIAL CURETTING: BENIGN EARLY SECRETORY ENDOMETRIUM. RIGHT TUBAL ADHESIONS, EXCISION: PARATUBAL CYST AND BENIGN FIBROMEMBRANOUS TISSUE. RIGHT OVARIAN CYST, CYSTECTOMY: BENIGN FOLLICULAR CYST. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-SEP-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINTS. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B40017) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CECLOR, DILAUDID AND YAZ. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED HYPERSENSITIVITY WITH DILAUDID; AND RASH WITH CECLOR. CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, OVARIAN CYST AND PARATUBAL CYST. ON (B)(6) 2019, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, HYSTEROSCOPY) AND SURGERY (D & C). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: LEFT FALLOPIAN TUBE- 5 TRAILING COILS, RIGHT TUBE- APPROXIMATELY 5 TRAILING COILS. SHE ALSO UNDERWENT CYSTECTOMY AND ENTEROLYSIS. DISCREPANCY NOTED IN LOT NUMBER (PFS VS. MR), AS PER MR ITS 840017. LAPAROSCOPY WITH RIGHT OVARIAN CYSTECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON (B)(6) 2014: NEGATIVE. ON (B)(6) 2016 SURGICAL PATHOLOGY REPORT REVEALED, ENDOMETRIAL CURETTING: BENIGN EARLY SECRETORY ENDOMETRIUM. RIGHT TUBAL ADHESIONS, EXCISION: PARATUBAL CYST AND BENIGN FIBROMEMBRANOUS TISSUE. RIGHT OVARIAN CYST, CYSTECTOMY: BENIGN FOLLICULAR CYST. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-SEP-2018: PFS AND MEDICAL RECORD RECEIVED. REPORTER'S INFORMATION AND LOT NUMBER WAS UPDATED. EVENTS ADDED: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA). CONCOMITANT DISEASES, HISTORICAL DRUG, HISTORICAL CONDITION AND LAB DATA WERE 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN :PELVIC') AND GENITAL HAEMORRHAGE ('BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B40017) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPAROUS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DILAUDID, CECLOR, LOESTRIN FE FROM 2011 TO (B)(6) 2012 AND YAZ. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED HYPERSENSITIVITY WITH DILAUDID; AND RASH WITH CECLOR. CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, OVARIAN CYST AND PARATUBAL CYST. CONCOMITANT PRODUCTS INCLUDED RIZATRIPTAN BENZOATE (MAXALT) SINCE 2014. IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN") AND BACK PAIN ("LOWER BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (D & C AND HYSTERECTOMY WITH BILATERAL SALPHINGECTOMY,HYSTEROSCOPY, D&C,LAPROSCOPY RIGHT OVARIN CYSTECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN AND BACK PAIN HAD RESOLVED AND THE VAGINAL HAEMORRHAGE AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: LEFT FALLOPIAN TUBE- 5 TRAILING COILS, RIGHT TUBE- APPROXIMATELY 5 TRAILING COILS. SHE ALSO UNDERWENT CYSTECTOMY AND ENTEROLYSIS. DISCREPANCY NOTED IN LOT NUMBER (PFS VS. MR), AS PER MR ITS 840017. LAPAROSCOPY WITH RIGHT OVARIAN CYSTECTOMY;. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON (B)(6) 2014: RESULTS: NEGATIVE. DIAGNOSTIC RESULTS: ON (B)(6) 2016 SURGICAL PATHOLOGY REPORT REVEALED, ENDOMETRIAL CURETTING: BENIGN EARLY SECRETORY ENDOMETRIUM. RIGHT TUBAL ADHESIONS, EXCISION: PARATUBAL CYST AND BENIGN FIBROMEMBRANOUS TISSUE. RIGHT OVARIAN CYST, CYSTECTOMY: BENIGN FOLLICULAR CYST. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-MAY-2019: PFS & MR RECEIVED. REPORTER'S INFORMATION WAS UPDATED. PATIENT'S DEMOGRAPHICS WERE ADDED. ADDED EVENT ABDOMINAL PAIN, LOW BACK PAIN, BLEEDING. UPDATED OUTCOME OF EVENT PELVIC PAIN, ABDOMINAL PAIN, LOW BACK PAIN FROM UNKNOWN TO RECOVERED/ RESOLVED. CONCOMITANT DRUG WERE ADDED. INCIDENT WE RECEIVED A LOT NUMBER/RETURNED SAMPLE IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. 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). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 834935 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B40017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | MAXALT |