ESSURE
Report
- Report Number
- 2951250-2019-07631
- Event Type
- Injury
- Date Received
- September 20, 2019
- Report Date
- July 2, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/CHRONIC PAIN') IN A 22-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922606) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE BLEEDING. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND ANXIETY. CONCOMITANT PRODUCTS INCLUDED GABAPENTIN, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA), PIROXICAM AND TRAMADOL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). ON (B)(6) 2012, THE PATIENT EXPERIENCED HOT FLUSH ("HOT FLASHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), METRORRHAGIA ("METORHAGIA (BLEEDING B/W PERIODS)"), GENITAL HAEMORRHAGE ("GEN. ABNORMAL BLEEDING (INTERPRETED AS GENERAL ABNORMAL BLEEDING)"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), VAGINAL INFECTION ("VAGINAL INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GI CONDITIONS"), ALOPECIA ("HAIR LOSS"), TOOTH DISORDER ("DENTAL PROBLEMS"), HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINE") AND ADNEXA UTERI PAIN ("RIGHT FALLOPIAN TUBE PAIN/LEFT FALLOPIAN TUBE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYST. (FULL), SALPING. (BILATERAL),OTHER). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND NAUSEA HAD RESOLVED, THE DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, MENORRHAGIA, METRORRHAGIA, GENITAL HAEMORRHAGE, PSYCHOLOGICAL TRAUMA, BLADDER DISORDER, CYSTITIS, URINARY TRACT DISORDER, VAGINAL INFECTION, URINARY TRACT INFECTION, VAGINAL DISCHARGE, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, TOOTH DISORDER, HEADACHE, MIGRAINE, HOT FLUSH, VAGINAL HAEMORRHAGE AND ADNEXA UTERI PAIN OUTCOME WAS UNKNOWN AND THE WEIGHT DECREASED HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI PAIN, ALOPECIA, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, MENORRHAGIA, METRORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),CHRONIC PELVIC PAIN, CHRONIC ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METORHAGIA (BLEEDING B/W PERIODS),GEN. ABNORM. BLEED (INTERPRETED AS GENERAL ABNORMAL BLEEDING), PSYCH INJURY, BLADDER PROBLEMS, BLADDER INFECTION, URINARY PROBLEMS, VAGINAL INFECTION, URINARY TRACT INFECTION, VAGINAL DISCHARGE, FATIGUE, GI CONDITIONS, HAIR LOSS, DENTAL PROBS., HEADACHES, MIGRAINE. DISCREPANCY: DATE OF INSERTION PREVIOUSLY REPORTED AS (B)(6) 2011 NOW IT IS REPORTED (B)(6) 2012. INSERTION DETAILS: TRAILING COILS: LEFT: 2 COILS RIGHT: 3 COILS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.9 KG/SQM. LOT NUMBER:922606 MANUFACTURING DATE: 2011-11 EXPIRATION DATE:2014-11 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-APR-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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/CHRONIC PAIN') IN A 22-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922606) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE BLEEDING. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND ANXIETY. CONCOMITANT PRODUCTS INCLUDED GABAPENTIN, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA), PIROXICAM AND TRAMADOL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). ON (B)(6) 2012, THE PATIENT EXPERIENCED HOT FLUSH ("HOT FLASHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), METRORRHAGIA ("METORHAGIA (BLEEDING B/W PERIODS)"), GENITAL HAEMORRHAGE ("GEN. ABNORMAL BLEEDING (INTERPRETED AS GENERAL ABNORMAL BLEEDING)"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), VAGINAL INFECTION ("VAGINAL INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GI CONDITIONS"), ALOPECIA ("HAIR LOSS"), TOOTH DISORDER ("DENTAL PROBLEMS"), HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINE") AND ADNEXA UTERI PAIN ("RIGHT FALLOPIAN TUBE PAIN/LEFT FALLOPIAN TUBE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYST. (FULL), SALPING. (BILATERAL),OTHER). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, NAUSEA AND WEIGHT DECREASED HAD RESOLVED AND THE DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, MENORRHAGIA, METRORRHAGIA, GENITAL HAEMORRHAGE, PSYCHOLOGICAL TRAUMA, BLADDER DISORDER, CYSTITIS, URINARY TRACT DISORDER, VAGINAL INFECTION, URINARY TRACT INFECTION, VAGINAL DISCHARGE, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, TOOTH DISORDER, HEADACHE, MIGRAINE, HOT FLUSH, VAGINAL HAEMORRHAGE AND ADNEXA UTERI PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI PAIN, ALOPECIA, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, MENORRHAGIA, METRORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),CHRONIC PELVIC PAIN, CHRONIC ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METORHAGIA (BLEEDING B/W PERIODS),GEN. ABNORMAL. BLEED (INTERPRETED AS GENERAL ABNORMAL BLEEDING), PSYCH INJURY, BLADDER PROBLEMS, BLADDER INFECTION, URINARY PROBLEMS, VAGINAL INFECTION, URINARY TRACT INFECTION, VAGINAL DISCHARGE, FATIGUE, GI CONDITIONS, HAIR LOSS, DENTAL PROBS., HEADACHES, MIGRAINE. DISCREPANCY: DATE OF INSERTION PREVIOUSLY REPORTED AS (B)(6) 2011 NOW IT IS REPORTED (B)(6) 2012. INSERTION DETAILS: TRAILING COILS: LEFT: 2 COILS RIGHT: 3 COILS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.9 KG/SQM. LOT NUMBER:922606 MANUFACTURING DATE: 2011-11 EXPIRATION DATE:2014-11 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: WEIGHT GAIN EVENT OUTCOME WERE UPDATED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/CHRONIC PAIN') IN A 22-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 922606) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE BLEEDING. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND ANXIETY. CONCOMITANT PRODUCTS INCLUDED GABAPENTIN, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA), PIROXICAM AND TRAMADOL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). ON (B)(6) 2012, THE PATIENT EXPERIENCED HOT FLASHES ("HOT FLASHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), METRORRHAGIA ("METORHAGIA (BLEEDING B / W PERIODS)"), GENITAL HAEMORRHAGE ("GEN. ABNORMAL BLEEDING (INTERPRETED AS GENERAL ABNORMAL BLEEDING)"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), VAGINAL INFECTION ("VAGINAL INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GI CONDITIONS"), ALOPECIA ("HAIR LOSS"), TOOTH DISORDER ("DENTAL PROBLEMS"), HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINE") AND ADNEXA UTERI PAIN ("RIGHT FALLOPIAN TUBE PAIN/LEFT FALLOPIAN TUBE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYST. (FULL), SALPING. (BILATERAL),OTHER). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND NAUSEA HAD RESOLVED, THE DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, MENORRHAGIA, METRORRHAGIA, GENITAL HAEMORRHAGE, PSYCHOLOGICAL TRAUMA, BLADDER DISORDER, CYSTITIS, URINARY TRACT DISORDER, VAGINAL INFECTION, URINARY TRACT INFECTION, VAGINAL DISCHARGE, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, TOOTH DISORDER, HEADACHE, MIGRAINE, HOT FLUSH, VAGINAL HAEMORRHAGE AND ADNEXA UTERI PAIN OUTCOME WAS UNKNOWN AND THE WEIGHT DECREASED HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI PAIN, ALOPECIA, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, MENORRHAGIA, METRORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),CHRONIC PELVIC PAIN, CHRONIC ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METORHAGIA (BLEEDING B / W PERIODS), GEN. ABNORM. BLEED (INTERPRETED AS GENERAL ABNORMAL BLEEDING), PSYCH INJURY, BLADDER PROBLEMS, BLADDER INFECTION, URINARY PROBLEMS, VAGINAL INFECTION, URINARY TRACT INFECTION, VAGINAL DISCHARGE, FATIGUE, GI CONDITIONS, HAIR LOSS, DENTAL PROBS., HEADACHES, MIGRAINE. DISCREPANCY: DATE OF INSERTION PREVIOUSLY REPORTED AS ON (B)(6) 2011 NOW IT IS REPORTED ON (B)(6) 2012. INSERTION DETAILS: TRAILING COILS: LEFT: 2 COILS RIGHT: 3 COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.9 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-MAR-2020: PFS & MR RECEIVED. PLAINTIFF DATE OF BIRTH WAS UPDATED. LOT NUMBER WAS ADDED. INSERTION DATE WAS UPDATED. NEW EVENTS HOT FLASHES, ABNORMAL BLEEDING (VAGINAL), NAUSEA, WEIGHT LOSS, PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST WAS ADDED. UPDATED OUTCOME OF EVENT PELVIC PAIN FROM UNKNOWN TO RECOVERED / RESOLVED. EVENT ONSET DATE WAS UPDATED. CONCOMITANT CONDITION, REPORTER, PATIENT DEMOGRAPHICS WAS 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/CHRONIC PAIN') AND GENITAL HAEMORRHAGE ('GEN. ABNORMAL BLEEDING (INTERPRETED AS GENERAL ABNORMAL BLEEDING)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), METRORRHAGIA ("METORHAGIA (BLEEDING B/W PERIODS)"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), VAGINAL INFECTION ("VAGINAL INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GI CONDITIONS"), ALOPECIA ("HAIR LOSS"), TOOTH DISORDER ("DENTAL PROBLEMS"), HEADACHE ("HEADACHES") AND MIGRAINE ("MIGRAINE"). THE PATIENT WAS TREATED WITH SURGERY (HYST. (FULL), SALPING. (BILATERAL),OTHER). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, MENORRHAGIA, METRORRHAGIA, GENITAL HAEMORRHAGE, PSYCHOLOGICAL TRAUMA, BLADDER DISORDER, CYSTITIS, URINARY TRACT DISORDER, VAGINAL INFECTION, URINARY TRACT INFECTION, VAGINAL DISCHARGE, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, TOOTH DISORDER, HEADACHE AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),CHRONIC PELVIC PAIN, CHRONIC ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METORHAGIA (BLEEDING B/W PERIODS),GEN. ABNORM. BLEED (INTERPRETED AS GENERAL ABNORMAL BLEEDING), PSYCH INJURY, BLADDER PROBLEMS, BLADDER INFECTION, URINARY PROBLEMS, VAGINAL INFECTION, URINARY TRACT INFECTION, VAGINAL DISCHARGE, FATIGUE, GI CONDITIONS, HAIR LOSS, DENTAL PROBS., HEADACHES, MIGRAINE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-SEP-2019: PFS RECEIVED: CASE HAS BECAME INCIDENT. PREVIOUSLY REPORTED EVENT ¿INJURY¿ REPLACE WITH NEW EVENT .NEW EVENTS ADDED: PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METRORRHAGIA (BLEEDING B/W PERIODS), GENERAL ABNORMAL BLEEDING, PSYCH INJURY, BLADDER PROBLEMS, BLADDER INFECTION, URINARY PROBLEMS ,VAGINAL INFECTION, UTI, VAGINAL DISCHARGE, FATIGUE, GI CONDITIONS, HAIR LOSS, DENTAL PROBLEMS., HEADACHES, MIGRAINE. REPORTER INFORMATION WERE UPDATED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 890174 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 922606 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Other| R | DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| GABAPENTIN| GABAPENTIN| GABAPENTIN| PIROXICAM| PIROXICAM| PIROXICAM| TRAMADOL| TRAMADOL| TRAMADOL |