ESSURE
Report
- Report Number
- 2951250-2020-15446
- Event Type
- Injury
- Date Received
- October 27, 2020
- Report Date
- January 12, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PAIN ('UTERINE PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 810877) INSERTED. 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 UTERINE PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUATIONS"), MENSTRUATION IRREGULAR ("IRREGULAR MENSTRUATION"), MENSTRUATION DELAYED ("SOMETIMES ABSENT MENSTRUATION"), ABDOMINAL DISTENSION ("BLOATING"), ALOPECIA ("HAIR LOSS"), VISUAL IMPAIRMENT ("VISION PROBLEMS"), BLADDER DISORDER ("BLADDER PROBLEMS"), ABDOMINAL PAIN LOWER ("CRAMPS / CHRONIC CRAMPING IN ABDOMEN"), PAINFUL HIPS ("STABBING PAIN IN HIPS"), MUSCLE SPASMS ("CHRONIC CRAMPING IN LEGS"), MYALGIA ("PAIN IN MUSCLES"), PAINFUL JOINTS ("PAIN IN JOINTS"), BACK PAIN ("PAIN IN LOWER BACK"), CHEST PAIN ("PAIN IN CHEST"), PAIN IN EXTREMITY ("PAIN IN LEGS"), NECK PAIN ("PAIN IN NECK"), SPINAL PAIN ("PAIN IN SPINE"), HEADACHE ("HEADACHES"), MEMORY IMPAIRMENT ("FORGETFULNESS"), TINNITUS ("TINNITUS") AND FATIGUE ("CHRONIC FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE AND FALLOPIAN TUBES REMOVED). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PAIN, ALOPECIA, VISUAL IMPAIRMENT, ABDOMINAL PAIN LOWER, PAINFUL HIPS, MUSCLE SPASMS, MYALGIA, PAINFUL JOINTS, BACK PAIN, CHEST PAIN, PAIN IN EXTREMITY, NECK PAIN, SPINAL PAIN AND HEADACHE HAD NOT RESOLVED, THE DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE MENSTRUATION IRREGULAR, MENSTRUATION DELAYED, ABDOMINAL DISTENSION, WEIGHT INCREASED, BLADDER DISORDER, MEMORY IMPAIRMENT, TINNITUS AND FATIGUE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, BACK PAIN, BLADDER DISORDER, CHEST PAIN, DYSMENORRHOEA, FATIGUE, HEADACHE, MEMORY IMPAIRMENT, MENSTRUATION DELAYED, MENSTRUATION IRREGULAR, MUSCLE SPASMS, MYALGIA, NECK PAIN, PAIN IN EXTREMITY, PAINFUL HIPS, SPINAL PAIN, TINNITUS, UTERINE PAIN, VISUAL IMPAIRMENT, WEIGHT INCREASED AND PAINFUL JOINTS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE IMPLANTED IN TWO STAGES: ON (B)(6) 2011, THE ESSURE WAS PLACED IN HER RIGHT FALLOPIAN TUBE, AND ON (B)(6) 2011, IN HER LEFT FALLOPIAN TUBE. THE SYMPTOMS BEGAN VERY SOON AFTER PLACEMENT OF THE ESSURE. SINCE THEN, SOME OF HER COMPLAINTS ARE GONE. SHE OCCASIONALLY STILL HAS PAIN IN HER LOWER BACK: BACK, HIP, UTERUS AND LEGS. LOT NUMBER: 810877, MANUFACTURE DATE: 2010-12, EXPIRATION DATE: 2013-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-DEC-2020: AFTER ESSURE REMOVAL, PART OF HER COMPLAINTS HAS RESOLVED. THE PATIENT CONTINUED TO HAVE PAIN IN HER LOWER BACK, BACK, HIP, UTERUS AND LEGS. SHE WAS UNDERGOING TREATMENT WITH HERGENERAL PRACTITIONER FOR THESE LASTING COMPLAINTS. THE REPORTER ALSO STATED THAT ALTHOUGH SHE HAD THE ESSURE REMOVED FOUR YEARS AGO, SHE STILL EXPERIENCES PAIN. AMENDMENT: DUE TO INTERNAL REVIEW LAST FOLLOW UP WAS NOT RECEIVED ON 31-DEC-2020 BUT ON 16-DEC-2020. 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 UTERINE PAIN ('UTERINE PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED. 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 UTERINE PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUATIONS"), MENSTRUATION IRREGULAR ("IRREGULAR MENSTRUATION"), MENSTRUATION DELAYED ("SOMETIMES ABSENT MENSTRUATION"), ABDOMINAL DISTENSION ("BLOATING"), ALOPECIA ("HAIR LOSS"), VISUAL IMPAIRMENT ("VISION PROBLEMS"), BLADDER DISORDER ("BLADDER PROBLEMS"), ABDOMINAL PAIN LOWER ("CRAMPS / CHRONIC CRAMPING IN ABDOMEN"), PAINFUL HIPS ("STABBING PAIN IN HIPS"), MUSCLE SPASMS ("CHRONIC CRAMPING IN LEGS"), MYALGIA ("PAIN IN MUSCLES"), PAINFUL JOINTS ("PAIN IN JOINTS"), BACK PAIN ("PAIN IN LOWER BACK"), CHEST PAIN ("PAIN IN CHEST"), PAIN IN EXTREMITY ("PAIN IN LEGS"), NECK PAIN ("PAIN IN NECK"), SPINAL PAIN ("PAIN IN SPINE"), HEADACHE ("HEADACHES"), MEMORY IMPAIRMENT ("FORGETFULNESS"), TINNITUS ("TINNITUS") AND FATIGUE ("CHRONIC FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE AND FALLOPIAN TUBES REMOVED). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PAIN, ALOPECIA, VISUAL IMPAIRMENT, ABDOMINAL PAIN LOWER, PAINFUL HIPS, MUSCLE SPASMS, MYALGIA, PAINFUL JOINTS, BACK PAIN, CHEST PAIN, PAIN IN EXTREMITY, NECK PAIN, SPINAL PAIN AND HEADACHE HAD NOT RESOLVED, THE DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE MENSTRUATION IRREGULAR, MENSTRUATION DELAYED, ABDOMINAL DISTENSION, WEIGHT INCREASED, BLADDER DISORDER, MEMORY IMPAIRMENT, TINNITUS AND FATIGUE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, BACK PAIN, BLADDER DISORDER, CHEST PAIN, DYSMENORRHOEA, FATIGUE, HEADACHE, MEMORY IMPAIRMENT, MENSTRUATION DELAYED, MENSTRUATION IRREGULAR, MUSCLE SPASMS, MYALGIA, NECK PAIN, PAIN IN EXTREMITY, PAINFUL HIPS, SPINAL PAIN, TINNITUS, UTERINE PAIN, VISUAL IMPAIRMENT, WEIGHT INCREASED AND PAINFUL JOINTS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE IMPLANTED IN TWO STAGES: ON (B)(6) 2011, THE ESSURE WAS PLACED IN HER RIGHT FALLOPIAN TUBE, AND ON (B)(6) 2011, IN HER LEFT FALLOPIAN TUBE. THE SYMPTOMS BEGAN VERY SOON AFTER PLACEMENT OF THE ESSURE. SINCE THEN, SOME OF HER COMPLAINTS ARE GONE. SHE OCCASIONALLY STILL HAS PAIN IN HER LOWER BACK: BACK, HIP, UTERUS AND LEGS. LOT NUMBER: 810877 MANUFACTURE DATE: 2010-12 EXPIRATION DATE: 2013-12 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-DEC-2020: AFTER ESSURE REMOVAL, PART OF HER COMPLAINTS HAS RESOLVED. THE PATIENT CONTINUED TO HAVE PAIN IN HER LOWER BACK, BACK, HIP, UTERUS AND LEGS. SHE WAS UNDERGOING TREATMENT WITH HER GENERAL PRACTITIONER FOR THESE LASTING COMPLAINTS. THE REPORTER ALSO STATED THAT ALTHOUGH SHE HAD THE ESSURE REMOVED FOUR YEARS AGO, SHE STILL EXPERIENCES PAIN. 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 MEDICAL DEVICE REMOVAL ('FOREIGN-BODY MATERIAL HAS BEEN REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED. 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 UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED INJURY ("SUFFER DAMAGES"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND INJURY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED INJURY AND MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DATE ALSO REPORTED AS (B)(6) 2011. LOT NUMBER: 810877 MANUFACTURE DATE: 2010-12 EXPIRATION DATE: 2013-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-NOV-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 MEDICAL DEVICE REMOVAL ('FOREIGN-BODY MATERIAL HAS BEEN REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED. 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 UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED INJURY ("SUFFER DAMAGES"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND INJURY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED INJURY AND MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DATE ALSO REPORTED AS (B)(6) 2011. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-NOV-2020: LOT NUMBER ADDED (810877). 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 UTERINE PAIN ('UTERINE PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED. 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 UTERINE PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUATIONS"), MENSTRUATION IRREGULAR ("IRREGULAR MENSTRUATION"), MENSTRUATION DELAYED ("SOMETIMES ABSENT MENSTRUATION"), ABDOMINAL DISTENSION ("BLOATING"), ALOPECIA ("HAIR LOSS"), VISUAL IMPAIRMENT ("VISION PROBLEMS"), BLADDER DISORDER ("BLADDER PROBLEMS"), ABDOMINAL PAIN LOWER ("CRAMPS / CHRONIC CRAMPING IN ABDOMEN"), PAINFUL HIPS ("STABBING PAIN IN HIPS"), MUSCLE SPASMS ("CHRONIC CRAMPING IN LEGS"), MYALGIA ("PAIN IN MUSCLES"), PAINFUL JOINTS ("PAIN IN JOINTS"), BACK PAIN ("PAIN IN LOWER BACK"), CHEST PAIN ("PAIN IN CHEST"), PAIN IN EXTREMITY ("PAIN IN LEGS"), NECK PAIN ("PAIN IN NECK "), SPINAL PAIN ("PAIN IN SPINE"), HEADACHE ("HEADACHES"), MEMORY IMPAIRMENT ("FORGETFULNESS"), TINNITUS ("TINNITUS") AND FATIGUE ("CHRONIC FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE AND FALLOPIAN TUBES REMOVED). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PAIN, DYSMENORRHOEA, MENSTRUATION IRREGULAR, MENSTRUATION DELAYED, ABDOMINAL DISTENSION, WEIGHT INCREASED, ALOPECIA, VISUAL IMPAIRMENT, BLADDER DISORDER, ABDOMINAL PAIN LOWER, PAINFUL HIPS, MUSCLE SPASMS, MYALGIA, PAINFUL JOINTS, BACK PAIN, CHEST PAIN, PAIN IN EXTREMITY, NECK PAIN, SPINAL PAIN, HEADACHE, MEMORY IMPAIRMENT, TINNITUS AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, BACK PAIN, BLADDER DISORDER, CHEST PAIN, DYSMENORRHOEA, FATIGUE, HEADACHE, MEMORY IMPAIRMENT, MENSTRUATION DELAYED, MENSTRUATION IRREGULAR, MUSCLE SPASMS, MYALGIA, NECK PAIN, PAIN IN EXTREMITY, PAINFUL HIPS, SPINAL PAIN, TINNITUS, UTERINE PAIN, VISUAL IMPAIRMENT, WEIGHT INCREASED AND PAINFUL JOINTS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE IMPLANTED IN TWO STAGES: ON 18 JULY 2011, THE ESSURE WAS PLACED IN HER RIGHT FALLOPIAN TUBE, AND ON 10 OCTOBER 2011, IN HER LEFT FALLOPIAN TUBE.THE SYMPTOMS BEGAN VERY SOON AFTER PLACEMENT OF THE ESSURE.SINCE THEN, SOME OF HER COMPLAINTS ARE GONE. SHE OCCASIONALLY STILL HAS PAIN IN HER LOWER BACK: BACK, HIP, UTERUS AND LEGS. LOT NUMBER: 810877 MANUFACTURE DATE: 2010-12 EXPIRATION DATE: 2013-12 QUALITY-SAFETY EVALUATION OF PTC:UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES:ON 16-DEC-2020: REPORTER, REMOVAL DATE AND EVENTS SEVERE PAIN DURING HER MENSTRUATIONS, IRREGULAR MENSTRUATION, SOMETIMES ABSENT MENSTRUATION, BLOATING, WEIGHT GAIN, HAIR LOSS, VISION PROBLEMS, BLADDER PROBLEMS, CRAMPS, STABBING PAIN IN HIPS, CHRONIC CRAMPING IN ABDOMEN, CHRONIC CRAMPING IN LEGS, PAIN IN MUSCLES, PAIN IN JOINTS, PAIN IN LOWER BACK, PAIN IN CHEST, PAIN IN LEGS, PAIN IN NECK, PAIN IN SPINE, HEADACHES, FORGETFULNESS, TINNITUS, CHRONIC FATIGUE AND UTERINE PAIN ADDED. EVENT MEDICAL DEVICE REMOVAL AND INJURY DELETED.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 CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('FOREIGN-BODY MATERIAL HAS BEEN REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. 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 UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED INJURY ("SUFFER DAMAGES"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND INJURY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED INJURY AND 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 (B)(6) 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('FOREIGN-BODY MATERIAL HAS BEEN REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. 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 UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED INJURY ("SUFFER DAMAGES"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND INJURY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED INJURY AND MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1204709 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810877 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |