ESSURE
Report
- Report Number
- 2951250-2018-00444
- Event Type
- Injury
- Date Received
- January 17, 2018
- Report Date
- May 6, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('DEVICE MIGRATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922610) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CAESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED CHEST TIGHTNESS, SHORTNESS OF BREATH, WHEEZING, ASTHMA, THROAT IRRITATION, PHARYNGITIS, PAIN ANKLE, SNORING AND TONSILLITIS. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY AND ABNORMAL BLEEDING"). IN (B)(6) 2014, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND TOOTH LOSS ("TOOTH LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("MENSTRUAL PAIN"), MENOMETRORRHAGIA ("IRREGULAR AND PROLONGED MENSTRUATION / IRREGULAR PERIODS"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MUSCLE SPASMS ("BACK SPASMS"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), MALAISE ("FEELING SICK"), ASTHENIA ("LOW ENERGY"), TOOTH DISORDER ("TEETH ISSUE/ I WEAR FLIPPER FOR MY TOP TEETH") AND ALLERGY TO METALS ("NICKEL ALLERGY") WITH PRURITUS. THE PATIENT WAS TREATED WITH LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) AND SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENOMETRORRHAGIA, DYSPAREUNIA, ABDOMINAL PAIN, MUSCLE SPASMS, TOOTH DISORDER AND ALLERGY TO METALS OUTCOME WAS UNKNOWN AND THE HEADACHE, TOOTH LOSS, BACK PAIN, MENSTRUATION IRREGULAR, MALAISE AND ASTHENIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ASTHENIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MALAISE, MENOMETRORRHAGIA, MENSTRUATION IRREGULAR, MUSCLE SPASMS, TOOTH DISORDER AND TOOTH LOSS TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: COIL IN PLACE AND FALLOPIAN TUBES WERE OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: NEW EVENT: ¿NICKEL ALLERGY¿ WITH SYMPTOM ¿ITCHING¿. TREATMENT DRUG XYZAL 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("DEVICE MIGRATION") AND GENITAL HAEMORRHAGE ("HEAVY AND ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922610) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CAESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED CHEST TIGHTNESS, SHORTNESS OF BREATH, WHEEZING, ASTHMA, THROAT IRRITATION, PHARYNGITIS, PAIN ANKLE, SNORING AND TONSILLITIS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("MENSTRUAL PAIN"), MENOMETRORRHAGIA ("IRREGULAR AND PROLONGED MENSTRUATION / IRREGULAR PERIODS"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MUSCLE SPASMS ("BACK SPASMS"), HEADACHE ("HEADACHES"), TOOTH LOSS ("TOOTH LOSS") AND BACK PAIN ("BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENOMETRORRHAGIA, DYSPAREUNIA, ABDOMINAL PAIN, MUSCLE SPASMS, HEADACHE, TOOTH LOSS AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENOMETRORRHAGIA, MUSCLE SPASMS AND TOOTH LOSS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: COIL IN PLACE AND FALLOPIAN TUBES WERE OCCLUDED QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-AUG-2018: AFTER AN INTERNAL REVIEW, IT WAS NOTICED THAT THE INTERVENTION REQUIRED (DEVICE) BOX WAS INADVERTENTLY UNTICKED DURING THE FOLLOW-UP FROM (B)(6) 2018. ACCORDING TO THE INFORMATION RECEIVED IN THE PREVIOUS FOLLOW-UP FROM (B)(6) 2018, ESSURE WAS REMOVED ON (B)(6) 2018, AND THEREFORE AN INTERVENTION OCCURRED. 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.
THE SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("DEVICE MIGRATION") AND GENITAL HAEMORRHAGE ("HEAVY AND ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922610) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CAESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED CHEST TIGHTNESS, SHORTNESS OF BREATH, WHEEZING, ASTHMA, THROAT IRRITATION, PHARYNGITIS, PAIN ANKLE, SNORING AND TONSILLITIS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("MENSTRUAL PAIN"), MENOMETRORRHAGIA ("IRREGULAR AND PROLONGED MENSTRUATION / IRREGULAR PERIODS"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MUSCLE SPASMS ("BACK SPASMS"), HEADACHE ("HEADACHES"), TOOTH LOSS ("TOOTH LOSS") AND BACK PAIN ("BACK PAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENOMETRORRHAGIA, DYSPAREUNIA, ABDOMINAL PAIN, MUSCLE SPASMS, HEADACHE, TOOTH LOSS AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENOMETRORRHAGIA, MUSCLE SPASMS AND TOOTH LOSS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE SYMPTOMS ARE SO SEVERE, PLAINTIFF IS DISCUSSING THE POSSIBILITY OF HAVING A HYSTERECTOMY TO REMOVE THE ESSURE DEVICE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: COIL IN PLACE AND FALLOPIAN TUBES WERE OCCLUDED MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JUN-2018: PFS+MR RECEIVED: NEW EVENT: BACK PAIN ADDED. IRREGULAR PERIODS CLUBBED TO PREVIOUS EVENT. REPORTER, PATIENT DEMOGRAPHIC INFORMATION, CONCOMITANT DISEASES, PRODUCT LOT NUMBER, PRODUCT STOP DATE 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("DEVICE MIGRATION") AND GENITAL HAEMORRHAGE ("HEAVY AND ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922610) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CAESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED CHEST TIGHTNESS, SHORTNESS OF BREATH, WHEEZING, ASTHMA, THROAT IRRITATION, PHARYNGITIS, PAIN ANKLE, SNORING AND TONSILLITIS. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6)-2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6)- 2014, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND TOOTH LOSS ("TOOTH LOSS"). IN (B)(6)- 2016, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("MENSTRUAL PAIN"), MENOMETRORRHAGIA ("IRREGULAR AND PROLONGED MENSTRUATION / IRREGULAR PERIODS"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MUSCLE SPASMS ("BACK SPASMS"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), MALAISE ("FEELING SICK") AND ASTHENIA ("LOW ENERGY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6)-2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENOMETRORRHAGIA, DYSPAREUNIA, ABDOMINAL PAIN AND MUSCLE SPASMS OUTCOME WAS UNKNOWN AND THE HEADACHE, TOOTH LOSS, BACK PAIN, MENSTRUATION IRREGULAR, MALAISE AND ASTHENIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ASTHENIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MALAISE, MENOMETRORRHAGIA, MENSTRUATION IRREGULAR, MUSCLE SPASMS AND TOOTH LOSS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: COIL IN PLACE AND FALLOPIAN TUBES WERE OCCLUDED QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)-2018: PLAINTIFF FACT SHEET-EVENTS IRREGULAR PERIOD, FEELING SICK, AND HAVING LOW ENERGY 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 DEVICE DISLOCATION ('DEVICE MIGRATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922610) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CAESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED CHEST TIGHTNESS, SHORTNESS OF BREATH, WHEEZING, ASTHMA, THROAT IRRITATION, PHARYNGITIS, PAIN ANKLE, SNORING AND TONSILLITIS. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY AND ABNORMAL BLEEDING"). IN (B)(6) 2014, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND TOOTH LOSS ("TOOTH LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("MENSTRUAL PAIN"), MENOMETRORRHAGIA ("IRREGULAR AND PROLONGED MENSTRUATION / IRREGULAR PERIODS"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MUSCLE SPASMS ("BACK SPASMS"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), MALAISE ("FEELING SICK"), ASTHENIA ("LOW ENERGY"), TOOTH DISORDER ("TEETH ISSUE/ I WEAR FLIPPER FOR MY TOP TEETH"), ALLERGY TO METALS ("NICKEL ALLERGY") WITH PRURITUS AND HAIR TEXTURE ABNORMAL ("HAIR IS BEEN GROWING THICKER"). THE PATIENT WAS TREATED WITH LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) AND SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENOMETRORRHAGIA, DYSPAREUNIA, ABDOMINAL PAIN, MUSCLE SPASMS, TOOTH DISORDER, ALLERGY TO METALS AND HAIR TEXTURE ABNORMAL OUTCOME WAS UNKNOWN AND THE HEADACHE, TOOTH LOSS, BACK PAIN, MENSTRUATION IRREGULAR, MALAISE AND ASTHENIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ASTHENIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HAIR TEXTURE ABNORMAL, HEADACHE, MALAISE, MENOMETRORRHAGIA, MENSTRUATION IRREGULAR, MUSCLE SPASMS, TOOTH DISORDER AND TOOTH LOSS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: COIL IN PLACE AND FALLOPIAN TUBES WERE OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY SAFETY EVALUATION OF PTC 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 DEVICE DISLOCATION ('DEVICE MIGRATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922610) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CAESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED CHEST TIGHTNESS, SHORTNESS OF BREATH, WHEEZING, ASTHMA, THROAT IRRITATION, PHARYNGITIS, PAIN ANKLE, SNORING AND TONSILLITIS. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY AND ABNORMAL BLEEDING"). IN (B)(6) 2014, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND TOOTH LOSS ("TOOTH LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("MENSTRUAL PAIN"), MENOMETRORRHAGIA ("IRREGULAR AND PROLONGED MENSTRUATION / IRREGULAR PERIODS"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MUSCLE SPASMS ("BACK SPASMS"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), MALAISE ("FEELING SICK"), ASTHENIA ("LOW ENERGY") AND TOOTH DISORDER ("TEETH ISSUE/ I WEAR FLIPPER FOR MY TOP TEETH"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENOMETRORRHAGIA, DYSPAREUNIA, ABDOMINAL PAIN, MUSCLE SPASMS AND TOOTH DISORDER OUTCOME WAS UNKNOWN AND THE HEADACHE, TOOTH LOSS, BACK PAIN, MENSTRUATION IRREGULAR, MALAISE AND ASTHENIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ASTHENIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MALAISE, MENOMETRORRHAGIA, MENSTRUATION IRREGULAR, MUSCLE SPASMS, TOOTH DISORDER AND TOOTH LOSS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: COIL IN PLACE AND FALLOPIAN TUBES WERE OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: SOCIAL MEDIA RECEIVED: NEW EVENTS: TEETH ISSUE WAS ADDED. REPORTER ADDED. EVENT GENITAL HAEMORRHAGE MADE MEDICALLY NON-SIGNIFICANT. 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 DEVICE DISLOCATION ('DEVICE MIGRATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922610) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CAESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED CHEST TIGHTNESS, SHORTNESS OF BREATH, WHEEZING, ASTHMA, THROAT IRRITATION, PHARYNGITIS, PAIN ANKLE, SNORING AND TONSILLITIS. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY AND ABNORMAL BLEEDING"). IN (B)(6) 2014, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND TOOTH LOSS ("TOOTH LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("MENSTRUAL PAIN"), MENOMETRORRHAGIA ("IRREGULAR AND PROLONGED MENSTRUATION / IRREGULAR PERIODS"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MUSCLE SPASMS ("BACK SPASMS"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), MALAISE ("FEELING SICK"), ASTHENIA ("LOW ENERGY"), TOOTH DISORDER ("TEETH ISSUE/ I WEAR FLIPPER FOR MY TOP TEETH"), ALLERGY TO METALS ("NICKEL ALLERGY") WITH PRURITUS AND HAIR GROWTH ABNORMAL ("HAIR IS BEEN GROWING THICKER"). THE PATIENT WAS TREATED WITH LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) AND SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENOMETRORRHAGIA, DYSPAREUNIA, ABDOMINAL PAIN, MUSCLE SPASMS, TOOTH DISORDER, ALLERGY TO METALS AND HAIR GROWTH ABNORMAL OUTCOME WAS UNKNOWN AND THE HEADACHE, TOOTH LOSS, BACK PAIN, MENSTRUATION IRREGULAR, MALAISE AND ASTHENIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ASTHENIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HAIR GROWTH ABNORMAL, HEADACHE, MALAISE, MENOMETRORRHAGIA, MENSTRUATION IRREGULAR, MUSCLE SPASMS, TOOTH DISORDER AND TOOTH LOSS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: COIL IN PLACE AND FALLOPIAN TUBES WERE OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: SOCIAL MEDIA REPORT RECEIVED: NEW REPORTER WAS ADDED. NEW EVENT HAIR IS BEEN GROWING THICKER WAS ADDED. 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 DEVICE DISLOCATION ("DEVICE MIGRATION") AND GENITAL HAEMORRHAGE ("HEAVY AND ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("MENSTRUAL PAIN"), MENOMETRORRHAGIA ("IRREGULAR AND PROLONGED MENSTRUATION"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MUSCLE SPASMS ("BACK SPASMS"), HEADACHE ("HEADACHES") AND TOOTH LOSS ("TOOTH LOSS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENOMETRORRHAGIA, DYSPAREUNIA, ABDOMINAL PAIN, MUSCLE SPASMS, HEADACHE AND TOOTH LOSS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENOMETRORRHAGIA, MUSCLE SPASMS AND TOOTH LOSS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE SYMPTOMS ARE SO SEVERE, PLAINTIFF IS DISCUSSING THE POSSIBILITY OF HAVING A HYSTERECTOMY TO REMOVE THE ESSURE DEVICE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: COIL IN PLACE AND FALLOPIAN TUBES WERE OCCLUDED. 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 |
|---|---|---|---|---|---|---|---|
| 42613 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 922610 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN |