ESSURE
Report
- Report Number
- 2951250-2019-09289
- Event Type
- Injury
- Date Received
- October 3, 2019
- Report Date
- May 13, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION') AND HAEMATEMESIS ('VOMITING BLOOD') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. (103471 ,225910 )-NOT VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HAEMATEMESIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("CHRONIC PELVIC PAIN"), ABDOMINAL PAIN ("CHRONIC ABDOMINAL PAIN"), BACK PAIN ("CHRONIC BACK PAIN"), MENORRHAGIA ("CHRONIC MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), VISUAL IMPAIRMENT ("VISION PROBLEMS"), MOOD SWINGS ("MOOD SWINGS"), THE FIRST EPISODE OF FEELING ABNORMAL ("BRAIN FOG"), TOOTH DISORDER ("DENTAL PROBLEMS"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), FUNGAL INFECTION ("INFECTION (OTHER): YEAST INFECTION"), ANXIETY ("ANXIETY"), URTICARIA ("RASHES OR SKIN CONDITIONS TYPE: HIVES"), THE SECOND EPISODE OF FEELING ABNORMAL ("BRAIN FOG") AND ARTHRALGIA ("JOINT PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, HAEMATEMESIS, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, DEPRESSION, URINARY TRACT INFECTION, VAGINAL INFECTION, MIGRAINE, HEADACHE, WEIGHT INCREASED, VISUAL IMPAIRMENT, MOOD SWINGS, TOOTH DISORDER, HYPERSENSITIVITY, FUNGAL INFECTION, ANXIETY, URTICARIA, WEIGHT DECREASED, THE LAST EPISODE OF FEELING ABNORMAL AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, ARTHRALGIA, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, FUNGAL INFECTION, HAEMATEMESIS, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT INFECTION, URTICARIA, VAGINAL INFECTION, VISUAL IMPAIRMENT, WEIGHT DECREASED, WEIGHT INCREASED, THE FIRST EPISODE OF FEELING ABNORMAL AND THE SECOND EPISODE OF FEELING ABNORMAL TO BE RELATED TO ESSURE. 2 LOT NUMBER (103471 , 225910 ) IS NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-APR-2020: UPDATE OF INFORMATION (BATCH IS INVALID). NO VALID LOT NUMBER WAS PROVIDED. 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 DEVICE DISLOCATION ('MIGRATION') AND HAEMATEMESIS ('VOMITING BLOOD') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 103471,225910-NOT VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HAEMATEMESIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("CHRONIC PELVIC PAIN"), ABDOMINAL PAIN ("CHRONIC ABDOMINAL PAIN"), BACK PAIN ("CHRONIC BACK PAIN"), MENORRHAGIA ("CHRONIC MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), VISUAL IMPAIRMENT ("VISION PROBLEMS"), MOOD SWINGS ("MOOD SWINGS"), THE FIRST EPISODE OF FEELING ABNORMAL ("BRAIN FOG"), TOOTH DISORDER ("DENTAL PROBLEMS"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), FUNGAL INFECTION ("INFECTION (OTHER): YEAST INFECTION"), ANXIETY ("ANXIETY"), URTICARIA ("RASHES OR SKIN CONDITIONS TYPE: HIVES"), THE SECOND EPISODE OF FEELING ABNORMAL ("BRAIN FOG") AND ARTHRALGIA ("JOINT PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, HAEMATEMESIS, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, DEPRESSION, URINARY TRACT INFECTION, VAGINAL INFECTION, MIGRAINE, HEADACHE, WEIGHT INCREASED, VISUAL IMPAIRMENT, MOOD SWINGS, TOOTH DISORDER, HYPERSENSITIVITY, FUNGAL INFECTION, ANXIETY, URTICARIA, WEIGHT DECREASED, THE LAST EPISODE OF FEELING ABNORMAL AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, ARTHRALGIA, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, FUNGAL INFECTION, HAEMATEMESIS, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT INFECTION, URTICARIA, VAGINAL INFECTION, VISUAL IMPAIRMENT, WEIGHT DECREASED, WEIGHT INCREASED, THE FIRST EPISODE OF FEELING ABNORMAL AND THE SECOND EPISODE OF FEELING ABNORMAL TO BE RELATED TO ESSURE. 2 LOT NUMBER (103471, 225910) IS NOT VALID QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-MAY-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 LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION') AND HAEMATEMESIS ('VOMITING BLOOD') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 103471/225910) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HAEMATEMESIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("CHRONIC PELVIC PAIN"), ABDOMINAL PAIN ("CHRONIC ABDOMINAL PAIN"), BACK PAIN ("CHRONIC BACK PAIN"), MENORRHAGIA ("CHRONIC MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), VISUAL IMPAIRMENT ("VISION PROBLEMS"), MOOD SWINGS ("MOOD SWINGS"), THE FIRST EPISODE OF FEELING ABNORMAL ("BRAIN FOG"), TOOTH DISORDER ("DENTAL PROBLEMS"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), FUNGAL INFECTION ("INFECTION (OTHER): YEAST INFECTION"), ANXIETY ("ANXIETY"), URTICARIA ("RASHES OR SKIN CONDITIONS TYPE: HIVES"), THE SECOND EPISODE OF FEELING ABNORMAL ("BRAIN FOG") AND ARTHRALGIA ("JOINT PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, HAEMATEMESIS, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, DEPRESSION, URINARY TRACT INFECTION, VAGINAL INFECTION, MIGRAINE, HEADACHE, WEIGHT INCREASED, VISUAL IMPAIRMENT, MOOD SWINGS, TOOTH DISORDER, HYPERSENSITIVITY, FUNGAL INFECTION, ANXIETY, URTICARIA, WEIGHT DECREASED, THE LAST EPISODE OF FEELING ABNORMAL AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, ARTHRALGIA, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, FUNGAL INFECTION, HAEMATEMESIS, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT INFECTION, URTICARIA, VAGINAL INFECTION, VISUAL IMPAIRMENT, WEIGHT DECREASED, WEIGHT INCREASED, THE FIRST EPISODE OF FEELING ABNORMAL AND THE SECOND EPISODE OF FEELING ABNORMAL TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-MAR-2020: SOCIAL MEDIA RECEIVED- NEW EVENT ALLERGIC OR HYPERSENSITIVITY REACTION, YEAST INFECTION, ANXIETY, RASHES OR SKIN CONDITIONS TYPE: HIVES, WEIGHT LOSS, BRAIN FOG, JOINT PAIN WERE ADDED. PT OF PSYCH INJURY WAS UPDATED AS DEPRESSION. LOT NUMBER WAS ADDED. REPORTERS WERE 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 DEVICE DISLOCATION ('MIGRATION') AND HAEMATEMESIS ('VOMITING BLOOD') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HAEMATEMESIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("CHRONIC PELVIC PAIN"), ABDOMINAL PAIN ("CHRONIC ABDOMINAL PAIN"), BACK PAIN ("CHRONIC BACK PAIN"), MENORRHAGIA ("CHRONIC MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), VISUAL IMPAIRMENT ("VISION PROBLEMS"), MOOD SWINGS ("MOOD SWINGS"), FEELING ABNORMAL ("BRAIN FOG") AND TOOTH DISORDER ("DENTAL PROBLEMS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, HAEMATEMESIS, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, PSYCHOLOGICAL TRAUMA, URINARY TRACT INFECTION, VAGINAL INFECTION, MIGRAINE, HEADACHE, WEIGHT INCREASED, VISUAL IMPAIRMENT, MOOD SWINGS, FEELING ABNORMAL AND TOOTH DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DEVICE DISLOCATION, FEELING ABNORMAL, HAEMATEMESIS, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, TOOTH DISORDER, URINARY TRACT INFECTION, VAGINAL INFECTION, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-SEP-2019: PFS RECEIVED: INJURY EVENT WAS UPDATED TO CHRONIC, PELVIC PAIN. NEW EVENTS ADDED - ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), PSYCH INJURY, MIGRATION, UTI, VAGINAL INFECTION, MIGRAINE, HEADACHES, WEIGHT LOSS, DENTAL PROBLEMS, VISION PROBLEMS, VOMITING BLOOD; BRAIN FOG, MOOD SWINGS. REPORTERS DETAILS UPDATED AND PATIENT DEMOGRAPHICS WERE ADDED. ESSURE INDICATION UPDATED AND EXPLANT DATE ADDED. 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 |
|---|---|---|---|---|---|---|---|
| 945337 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 103471,225910-NOTVALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |