ESSURE
Report
- Report Number
- 2951250-2019-01409
- Event Type
- Injury
- Date Received
- April 22, 2019
- Date of Event
- December 1, 2016
- Report Date
- January 7, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN\PAIN IN LOWER PELVIS FOLLOWING OVULATION\DEBILITATING PAIN\CHRONI') AND MENORRHAGIA ('ABNORMAL BLEEDING ( MENORRHAGIA)/HYPERMENORRHEA/ABNORMALLY HEAVY BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 976389- INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED MOTRIN CHILDREN. THE PATIENT'S MEDICAL HISTORY INCLUDED BLOATING, GERD, SINUS DISORDER AND NICKEL SENSITIVITY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD AND MIRENA. CONCOMITANT PRODUCTS INCLUDED NAPROXEN SODIUM (ALEVE). ON AN UNKNOWN DATE, THE PATIENT STARTED MOTRIN CHILDREN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED REPRODUCTIVE TRACT DISORDER ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION"), DYSMENORRHOEA ("DYSMENORRHEA/DYSMENORRHEA (CRAMPING)"), FALLOPIAN TUBE CYST ("FALLOPIAN CYST"), POST ABLATION TUBAL STERILISATION SYNDROME ("POST ABLATION SYNDROME"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), METRORRHAGIA ("METRORRHAGIA (BLEEDING B/W PERIODS)"), ANXIETY ("MENTAL ANGUISH/ANXIETY"), ANHEDONIA ("LOSS OF ENJOYMENT OF LIFE"), EMOTIONAL DISTRESS ("HUMILIATION"), DEFORMITY ("DISFIGUREMENT"), PSYCHOLOGICAL TRAUMA ("PSYCHOLOGICAL HARM/ PHYSICAL INJURIES"), PAIN ("GENERAL PAIN AND SUFFERING") AND GENERAL PHYSICAL HEALTH DETERIORATION ("BODILY IMPAIRMENT/ DEGRADATION/ GENERAL DAMAGES/ SPECIAL DAMAGES"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY) - LAPAROSCOPIC). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, BACK PAIN, METRORRHAGIA, ANXIETY, ANHEDONIA, EMOTIONAL DISTRESS, DEFORMITY, PSYCHOLOGICAL TRAUMA, PAIN AND GENERAL PHYSICAL HEALTH DETERIORATION HAD RESOLVED AND THE REPRODUCTIVE TRACT DISORDER, FALLOPIAN TUBE CYST AND POST ABLATION TUBAL STERILISATION SYNDROME OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANHEDONIA, ANXIETY, BACK PAIN, DEFORMITY, DYSMENORRHOEA, DYSPAREUNIA, EMOTIONAL DISTRESS, FALLOPIAN TUBE CYST, GENERAL PHYSICAL HEALTH DETERIORATION, MENORRHAGIA, METRORRHAGIA, PAIN, PELVIC PAIN, POST ABLATION TUBAL STERILISATION SYNDROME, PSYCHOLOGICAL TRAUMA, REPRODUCTIVE TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PAIN, OTHER INJURIES/SYMPTOM, BLEEDING, ANHEDONIA, HUMILIATION, DISFIGUREMENT, PSYCHOLOGICAL TRAUMA, GENERAL BODY PAIN, GENERAL PHYSICAL HEALTH DETERIORATION, ANXIETY, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHEA, DYSPAREUNIA, MENORRHAGIA, METRORRHAGIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULT: EVERYTHING LOOKS GOOD. BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : DYSMENORRHEA, MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-DEC-2019: PFS RECEIVED: NEWLY ADDED EVENTS- ANHEDONIA, HUMILIATION, DISFIGUREMENT, PSYCHOLOGICAL TRAUMA, GENERAL BODY PAIN, GENERAL PHYSICAL HEALTH DETERIORATION , REPORTER WAS ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN\PAIN IN LOWER PELVIS FOLLOWING OVULATION\DEBILITATING PAIN\CHRONI') AND MENORRHAGIA ('ABNORMAL BLEEDING ( MENORRHAGIA)/HYPERMENORRHEA/ABNORMALLY HEAVY BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 976389- NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED MOTRIN CHILDREN. THE PATIENT'S MEDICAL HISTORY INCLUDED BLOATING, GERD, SINUS DISORDER AND NICKEL SENSITIVITY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD AND MIRENA. CONCOMITANT PRODUCTS INCLUDED NAPROXEN SODIUM (ALEVE). ON AN UNKNOWN DATE, THE PATIENT STARTED MOTRIN CHILDREN AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED REPRODUCTIVE TRACT DISORDER ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION"), DYSMENORRHOEA ("DYSMENORRHEA/DYSMENORRHEA (CRAMPING)"), FALLOPIAN TUBE CYST ("FALLOPIAN CYST"), POST ABLATION TUBAL STERILISATION SYNDROME ("POST ABLATION SYNDROME"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), METRORRHAGIA ("METRORRHAGIA (BLEEDING B/W PERIODS)") AND ANXIETY ("MENTAL ANGUISH/ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY) - LAPAROSCOPIC). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, BACK PAIN, METRORRHAGIA AND ANXIETY HAD RESOLVED AND THE REPRODUCTIVE TRACT DISORDER, FALLOPIAN TUBE CYST AND POST ABLATION TUBAL STERILISATION SYNDROME OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE CYST, MENORRHAGIA, METRORRHAGIA, PELVIC PAIN, POST ABLATION TUBAL STERILISATION SYNDROME, REPRODUCTIVE TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PAIN, OTHER INJURIES/SYMPTOM, BLEEDING DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULT: EVERYTHING LOOKS GOOD. BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : DYSMENORRHEA, MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-SEP-2019: PFS RECEIVED. REPORTER INFORMATION ADDED. EVENT : DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), ABDOMINAL PAIN, BACK PAIN, METRORRHAGIA (BLEEDING B/W PERIODS), GENERAL PAIN AND SUFFERING, MENTAL ANGUISH/ANXIETY ADDED. OUTCOME OF THE EVENT PAIN, BLEEDING ADDED. NO VALID 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN\PAIN IN LOWER PELVIS FOLLOWING OVULATION\DEBILITATING PAIN\ ") AND MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)/HYPERMENORRHEA/ABNORMALLY HEAVY BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 976389- NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED MOTRIN CHILDREN. THE PATIENT'S MEDICAL HISTORY INCLUDED BLOATING, GERD AND SINUS DISORDER. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD AND MIRENA. CONCOMITANT PRODUCTS INCLUDED NAPROXEN SODIUM (ALEVE). ON AN UNKNOWN DATE, THE PATIENT STARTED MOTRIN CHILDREN AT AN UNSPECIFIED DOSE AND FREQUENCY. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), REPRODUCTIVE TRACT DISORDER ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION"), DYSMENORRHOEA ("DYSMENORRHEA"), FALLOPIAN TUBE CYST ("FALLOPIAN CYST") AND POST ABLATION TUBAL STERILISATION SYNDROME ("POST ABLATION SYNDROME"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY) - LAPAROSCOPIC). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE REPRODUCTIVE TRACT DISORDER, DYSMENORRHOEA, FALLOPIAN TUBE CYST AND POST ABLATION TUBAL STERILISATION SYNDROME OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, FALLOPIAN TUBE CYST, MENORRHAGIA, PELVIC PAIN, POST ABLATION TUBAL STERILISATION SYNDROME, REPRODUCTIVE TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULT: EVERYTHING LOOKS GOOD. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : DYSMENORRHEA, MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-APR-2019: UPDATE OF INFORMATION (BATCH IS NOT VALID) INCIDENT 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN\PAIN IN LOWER PELVIS FOLLOWING OVULATION\DEBILITATING PAIN\') AND MENORRHAGIA ('ABNORMAL BLEEDING ( MENORRHAGIA)/HYPERMENORRHEA/ABNORMALLY HEAVY BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 976389- NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED MOTRIN CHILDREN. THE PATIENT'S MEDICAL HISTORY INCLUDED BLOATING, GERD, SINUS DISORDER AND NICKEL SENSITIVITY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA AND IUD. CONCOMITANT PRODUCTS INCLUDED NAPROXEN SODIUM (ALEVE). ON AN UNKNOWN DATE, THE PATIENT STARTED MOTRIN CHILDREN AT AN UNSPECIFIED DOSE AND FREQUENCY. IN AUGUST 2012, THE PATIENT HAD ESSURE INSERTED. IN DECEMBER 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED REPRODUCTIVE TRACT DISORDER ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION"), DYSMENORRHOEA ("DYSMENORRHEA"), FALLOPIAN TUBE CYST ("FALLOPIAN CYST") AND POST ABLATION TUBAL STERILISATION SYNDROME ("POST ABLATION SYNDROME"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY) - LAPAROSCOPIC). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED, THE REPRODUCTIVE TRACT DISORDER, FALLOPIAN TUBE CYST AND POST ABLATION TUBAL STERILISATION SYNDROME OUTCOME WAS UNKNOWN AND THE DYSMENORRHOEA WAS RESOLVING. THE REPORTER CONSIDERED DYSMENORRHOEA, FALLOPIAN TUBE CYST, MENORRHAGIA, PELVIC PAIN, POST ABLATION TUBAL STERILISATION SYNDROME, REPRODUCTIVE TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULT: EVERYTHING LOOKS GOOD. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : DYSMENORRHEA, MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JUL-2019: PFS RECEIVED OUTCOME OF EVENT " DYSMENORRHEA" WAS UPDATED AS RECOVERING. INCIDENT: NO VALID 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN\PAIN IN LOWER PELVIS FOLLOWING OVULATION\DEBILITATING PAIN\") AND MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)/HYPERMENORRHEA/ABNORMALLY HEAVY BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 976389) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED MOTRIN CHILDREN. THE PATIENT'S MEDICAL HISTORY INCLUDED BLOATING, GERD AND SINUS DISORDER. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD AND MIRENA. CONCOMITANT PRODUCTS INCLUDED NAPROXEN SODIUM (ALEVE). ON AN UNKNOWN DATE, THE PATIENT STARTED MOTRIN CHILDREN AT AN UNSPECIFIED DOSE AND FREQUENCY. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), REPRODUCTIVE TRACT DISORDER ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION"), DYSMENORRHOEA ("DYSMENORRHEA"), FALLOPIAN TUBE CYST ("FALLOPIAN CYST") AND POST ABLATION TUBAL STERILISATION SYNDROME ("POST ABLATION SYNDROME"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY) - LAPAROSCOPIC). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE REPRODUCTIVE TRACT DISORDER, DYSMENORRHOEA, FALLOPIAN TUBE CYST AND POST ABLATION TUBAL STERILISATION SYNDROME OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, FALLOPIAN TUBE CYST, MENORRHAGIA, PELVIC PAIN, POST ABLATION TUBAL STERILISATION SYNDROME, REPRODUCTIVE TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULT: EVERYTHING LOOKS GOOD. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : DYSMENORRHEA, MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-APR-2019: CASE BECOME VALID. PFS RECEIVED. REPORTER ADDED, PLAINTIFFS ADDRESS UPDATED, PATIENT DEMOGRAPHIC ADDED. AKA ADDED, PRODUCT INDICATION AND LOT NUMBER ADDED. EVENTS ADDED ARE AS FOLLOWS- PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, REPRODUCTIVE SYSTEM DISORDER, FALLOPIAN TUBE CYST AND POST ABLATION SYNDROME. EVENTS ONSET DATE AND SEVERITY ADDED. CONCOMITANT DRUG AND MEDICAL HISTORY ADDED. LAB DATA ADDED. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330042 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 976389- INV | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other| R | ALEVE| ALEVE| ALEVE| ALEVE| ALEVE| ALEVE |