ESSURE
Report
- Report Number
- 2951250-2021-00274
- Event Type
- Injury
- Date Received
- January 27, 2021
- Report Date
- February 4, 2022
- 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
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('SEVERE (CHRONIC) PAIN IN THE ABDOMEN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PROCEDURAL PAIN ("PAIN SYMPTOMS IMMEDIATELY AFTER IMPLANTATION"), BACK PAIN ("PAIN IN BACK"), HYPERSENSITIVITY ("ALLERGIC REACTION"), HEADACHE ("PAIN IN HEAD"), MENSTRUAL DISORDER ("CHANGE IN MENSTRUATION CYCLE"), HEAVY MENSTRUAL BLEEDING ("ABNORMALLY LARGE AMOUNT OF BLOOD LOSS (DURING MENSTRUATION)"), ARTHRALGIA ("PAIN IN HIPS"), FATIGUE ("EXTREME AND CHRONIC FATIGUE"), AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS") AND PREMATURE MENOPAUSE ("PREMATURE MENOPAUSE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, PROCEDURAL PAIN, BACK PAIN, HYPERSENSITIVITY, HEADACHE, MENSTRUAL DISORDER, HEAVY MENSTRUAL BLEEDING, ARTHRALGIA, FATIGUE, AMNESIA, DISTURBANCE IN ATTENTION, HORMONE LEVEL ABNORMAL AND PREMATURE MENOPAUSE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, BACK PAIN, DISTURBANCE IN ATTENTION, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MENSTRUAL DISORDER, PREMATURE MENOPAUSE AND PROCEDURAL PAIN TO BE RELATED TO ESSURE. LOT NUMBER: 945067 MANUFACTURING DATE: 2012-01 EXPIRATION DATE: 2015-01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-JUN-2021: 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 CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('SEVERE (CHRONIC) PAIN IN THE ABDOMEN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PROCEDURAL PAIN ("PAIN SYMPTOMS IMMEDIATELY AFTER IMPLANTATION"), BACK PAIN ("PAIN IN BACK"), HYPERSENSITIVITY ("ALLERGIC REACTION"), HEADACHE ("PAIN IN HEAD"), MENSTRUAL DISORDER ("CHANGE IN MENSTRUATION CYCLE"), HEAVY MENSTRUAL BLEEDING ("ABNORMALLY LARGE AMOUNT OF BLOOD LOSS (DURING MENSTRUATION)"), ARTHRALGIA ("PAIN IN HIPS"), FATIGUE ("EXTREME AND CHRONIC FATIGUE"), AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS") AND PREMATURE MENOPAUSE ("PREMATURE MENOPAUSE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, PROCEDURAL PAIN, BACK PAIN, HYPERSENSITIVITY, HEADACHE, MENSTRUAL DISORDER, HEAVY MENSTRUAL BLEEDING, ARTHRALGIA, FATIGUE, AMNESIA, DISTURBANCE IN ATTENTION, HORMONE LEVEL ABNORMAL AND PREMATURE MENOPAUSE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, BACK PAIN, DISTURBANCE IN ATTENTION, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MENSTRUAL DISORDER, PREMATURE MENOPAUSE AND PROCEDURAL PAIN TO BE RELATED TO ESSURE. LOT NUMBER: 945067, MANUFACTURING DATE: 2012-01, EXPIRATION DATE: 2015-01. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-JUN-2021: 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 CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('SEVERE (CHRONIC) PAIN IN THE ABDOMEN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN ("PAIN SYMPTOMS IMMEDIATELY AFTER IMPLANTATION"), BACK PAIN ("PAIN IN BACK"), HYPERSENSITIVITY ("ALLERGIC REACTION"), HEADACHE ("PAIN IN HEAD"), MENSTRUATION IRREGULAR ("CHANGE IN MENSTRUATION CYCLE"), HEAVY MENSTRUAL BLEEDING ("ABNORMALLY LARGE AMOUNT OF BLOOD LOSS (DURING MENSTRUATION)"), ARTHRALGIA ("PAIN IN HIPS"), FATIGUE ("EXTREME AND CHRONIC FATIGUE"), AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS") AND PREMATURE MENOPAUSE ("PREMATURE MENOPAUSE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, PAIN, BACK PAIN, HYPERSENSITIVITY, HEADACHE, MENSTRUATION IRREGULAR, HEAVY MENSTRUAL BLEEDING, ARTHRALGIA, FATIGUE, AMNESIA, DISTURBANCE IN ATTENTION, HORMONE LEVEL ABNORMAL AND PREMATURE MENOPAUSE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, BACK PAIN, DISTURBANCE IN ATTENTION, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MENSTRUATION IRREGULAR, PAIN AND PREMATURE MENOPAUSE TO BE RELATED TO ESSURE. LOT NUMBER: 945067, MANUFACTURING DATE: 2012-01, EXPIRATION DATE: 2015-01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: EVENT FOREIGN-BODY MATERIAL HAS BEEN REMOVED DELETED. EVENTS PAIN SYMPTOMS IMMEDIATELY AFTER IMPLANTATION, SEVERE (CHRONIC) PAIN IN THE ABDOMEN, PAIN IN BACK, PAIN IN HIPS, PAIN IN HEAD, EXTREME AND CHRONIC FATIGUE, MEMORY LOSS, CONCENTRATION PROBLEMS, CHANGE IN MENSTRUATION CYCLE, ABNORMALLY LARGE AMOUNT OF BLOOD LOSS (DURING MENSTRUATION), HORMONAL PROBLEMS, ALLERGIC REACTION AND PREMATURE MENOPAUSE 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 CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('FOREIGN MATERIAL HAS BEEN REMOVED FROM MY BODY') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. LOT NUMBER: 945067 MANUFACTURING DATE: 2012-01 EXPIRATION DATE: 2015-01 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-FEB-2021: 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 CONSUMER ( AND SUBSEQUENTLY BY A LAWYER) AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('SEVERE (CHRONIC) PAIN IN THE ABDOMEN') AND FALLOPIAN TUBE PERFORATION ('PERFORATION OF THE FALLOPIAN TUBES') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) 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 ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PROCEDURAL PAIN ("PAIN SYMPTOMS IMMEDIATELY AFTER IMPLANTATION"), BACK PAIN ("PAIN IN BACK"), HYPERSENSITIVITY ("ALLERGIC REACTION"), HEADACHE ("PAIN IN HEAD"), MENSTRUAL DISORDER ("CHANGE IN MENSTRUATION CYCLE"), HEAVY MENSTRUAL BLEEDING ("ABNORMALLY LARGE AMOUNT OF BLOOD LOSS (DURING MENSTRUATION)"), ARTHRALGIA ("PAIN IN HIPS"), FATIGUE ("EXTREME AND CHRONIC FATIGUE"), AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS"), PREMATURE MENOPAUSE ("PREMATURE MENOPAUSE"), FEELING ABNORMAL ("BRAIN FOG "), TOOTH DISORDER ("DENTAL PROBLEMS ") AND INFLAMMATION ("INFLAMMATIONS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, FALLOPIAN TUBE PERFORATION, PROCEDURAL PAIN, BACK PAIN, HYPERSENSITIVITY, HEADACHE, MENSTRUAL DISORDER, HEAVY MENSTRUAL BLEEDING, ARTHRALGIA, FATIGUE, AMNESIA, DISTURBANCE IN ATTENTION, HORMONE LEVEL ABNORMAL, PREMATURE MENOPAUSE, FEELING ABNORMAL, TOOTH DISORDER AND INFLAMMATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, BACK PAIN, DISTURBANCE IN ATTENTION, FALLOPIAN TUBE PERFORATION, FATIGUE, FEELING ABNORMAL, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, INFLAMMATION, MENSTRUAL DISORDER, PREMATURE MENOPAUSE, PROCEDURAL PAIN AND TOOTH DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DATE REPORTED AS (B)(6) 2012 (APPROXIMATELY). LOT NUMBER: 945067, MANUFACTURING DATE: 2012-01, AND EXPIRATION DATE: 2015-01. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JAN-2022: THE FOLLOWING EVENTS WERE ADDED: BRAIN FOG, PERFORATION OF THE FALLOPIAN TUBES, DENTAL PROBLEMS AND INFLAMMATIONS. 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 ABDOMINAL PAIN ('SEVERE (CHRONIC) PAIN IN THE ABDOMEN') AND FALLOPIAN TUBE PERFORATION ('PERFORATION OF THE FALLOPIAN TUBES') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) 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 ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PROCEDURAL PAIN ("PAIN SYMPTOMS IMMEDIATELY AFTER IMPLANTATION"), BACK PAIN ("PAIN IN BACK"), HYPERSENSITIVITY ("ALLERGIC REACTION"), HEADACHE ("PAIN IN HEAD"), MENSTRUAL DISORDER ("CHANGE IN MENSTRUATION CYCLE"), HEAVY MENSTRUAL BLEEDING ("ABNORMALLY LARGE AMOUNT OF BLOOD LOSS (DURING MENSTRUATION)"), ARTHRALGIA ("PAIN IN HIPS"), FATIGUE ("EXTREME AND CHRONIC FATIGUE"), AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS"), PREMATURE MENOPAUSE ("PREMATURE MENOPAUSE"), FEELING ABNORMAL ("BRAIN FOG "), TOOTH DISORDER ("DENTAL PROBLEMS ") AND INFLAMMATION ("INFLAMMATIONS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, FALLOPIAN TUBE PERFORATION, PROCEDURAL PAIN, BACK PAIN, HYPERSENSITIVITY, HEADACHE, MENSTRUAL DISORDER, HEAVY MENSTRUAL BLEEDING, ARTHRALGIA, FATIGUE, AMNESIA, DISTURBANCE IN ATTENTION, HORMONE LEVEL ABNORMAL, PREMATURE MENOPAUSE, FEELING ABNORMAL, TOOTH DISORDER AND INFLAMMATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, BACK PAIN, DISTURBANCE IN ATTENTION, FALLOPIAN TUBE PERFORATION, FATIGUE, FEELING ABNORMAL, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, INFLAMMATION, MENSTRUAL DISORDER, PREMATURE MENOPAUSE, PROCEDURAL PAIN AND TOOTH DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DATE REPORTED AS (B)(6) 2012 (APPROXIMATELY). LOT NUMBER: 945067. MANUFACTURING DATE: 2012-01. EXPIRATION DATE: 2015-01. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-FEB-2022: 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 CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('FOREIGN MATERIAL HAS BEEN REMOVED FROM MY BODY') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136148 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 945067 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention| O |