ESSURE
Report
- Report Number
- 2951250-2019-05427
- Event Type
- Injury
- Date Received
- September 5, 2019
- Report Date
- February 10, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION'), MENOMETRORRHAGIA ('ABNORMAL BLEEDING: HEAVY FLOW AND PASSAGE OF CLOTS, MENSES OCCURING EVERY 2-3 WEEKS AVERAGING 10-14 DAYS IN DURATION') AND MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627097) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PAP SMEAR ABNORMAL, KIDNEY STONES, CERVICAL DYSPLASIA, ASTHMA AND HYPERTENSION. CONCURRENT CONDITIONS INCLUDED ANXIETY DISORDER, DEPRESSION, OVARIAN CYST, MENOMETRORRHAGIA, UTERINE LEIOMYOMA, FREQUENCY OF MENSES, STRESS, PNEUMONIA, MYOCARDIAL INFARCTION, UTERINE BLEEDING, LOW BACK PAIN, CONSTIPATION AND UTERINE FIBROID. CONCOMITANT PRODUCTS INCLUDED APREMILAST (OTEZLA), DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), DIAZEPAM (VALIUM), DILTIAZEM, FERROUS ASPARTO GLYCINATE;FERROUS FUMARATE (TANDEM), IBUPROFEN AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENOMETRORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), PSORIASIS ("AUTOIMMUNE DISORDER-TYPE OF DISORDER: PLAQUE PSORAISIS"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), HOT FLUSH ("HOT FLASHES") AND MOOD SWINGS ("MOOD SWINGS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT INCREASED ("WEIGHT GAIN/ LOSS( SPECIFY WHICH ONE ) WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND SALPINGECTOMY BILATERAL, HYSTERECTOMY FULL OOPHORECTOMY (BILATERAL REMOVAL OF OVARIES)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PSORIASIS, BLADDER DISORDER, URINARY TRACT DISORDER, HORMONE LEVEL ABNORMAL, FATIGUE, ALOPECIA, WEIGHT INCREASED, HOT FLUSH AND MOOD SWINGS OUTCOME WAS UNKNOWN AND THE MENOMETRORRHAGIA, MENORRHAGIA, PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BLADDER DISORDER, DEVICE DISLOCATION, FATIGUE, HORMONE LEVEL ABNORMAL, HOT FLUSH, MENOMETRORRHAGIA, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN, PSORIASIS, URINARY TRACT DISORDER AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR FOLLOWING EVENTS PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), PLAQUE PSORIASIS, MIGRATION, BLADDER PROBLEMS, URINARY PROBLEMS, HORMONAL CHANGES, FATIGUE, HAIR LOSS, WEIGHT GAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2009: BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING ONES WAS CONFIRMED IN PATIENT MEDICAL RECORDS: PELVIC PAIN, FATIGUE, MENOMETRORRHAGIA, MENORRHAGIA, PSORIASIS. LOT NUMBER:627097, MANUFACTURE DATE:2008/04, EXPIRATION DATE:2010/04. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-OCT-2019: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: WE RECEIVED A LOT NUMBER. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION'), MENOMETRORRHAGIA ('ABNORMAL BLEEDING: HEAVY FLOW AND PASSAGE OF CLOTS, MENSES OCCURING EVERY 2-3 WEEKS AVERAGING 10-14 DAYS IN DURATION') AND MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627097) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PAP SMEAR ABNORMAL, KIDNEY STONES, CERVICAL DYSPLASIA, ASTHMA AND HYPERTENSION. CONCURRENT CONDITIONS INCLUDED ANXIETY DISORDER, DEPRESSION, OVARIAN CYST, MENOMETRORRHAGIA, UTERINE LEIOMYOMA, FREQUENCY OF MENSES, STRESS, PNEUMONIA, MYOCARDIAL INFARCTION, UTERINE BLEEDING, LOW BACK PAIN, CONSTIPATION AND UTERINE FIBROID. CONCOMITANT PRODUCTS INCLUDED APREMILAST (OTEZLA), DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), DIAZEPAM (VALIUM), DILTIAZEM, FERROUS ASPARTO GLYCINATE;FERROUS FUMARATE (TANDEM), IBUPROFEN AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENOMETRORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), PSORIASIS ("AUTOIMMUNE DISORDER-TYPE OF DISORDER: PLAQUE PSORAISIS"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), HOT FLUSH ("HOT FLASHES") AND MOOD SWINGS ("MOOD SWINGS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT INCREASED ("WEIGHT GAIN/ LOSS( SPECIFY WHICH ONE ) WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND SALPINGECTOMY BILATERAL, HYSTERECTOMY FULL OOPHORECTOMY (BILATERAL REMOVAL OF OVARIES)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PSORIASIS, BLADDER DISORDER, URINARY TRACT DISORDER, HORMONE LEVEL ABNORMAL, FATIGUE, ALOPECIA, WEIGHT INCREASED, HOT FLUSH AND MOOD SWINGS OUTCOME WAS UNKNOWN AND THE MENOMETRORRHAGIA, MENORRHAGIA, PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BLADDER DISORDER, DEVICE DISLOCATION, FATIGUE, HORMONE LEVEL ABNORMAL, HOT FLUSH, MENOMETRORRHAGIA, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN, PSORIASIS, URINARY TRACT DISORDER AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR FOLLOWING EVENTS PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), PLAQUE PSORIASIS, MIGRATION, BLADDER PROBLEMS, URINARY PROBLEMS, HORMONAL CHANGES, FATIGUE, HAIR LOSS, WEIGHT GAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2009: BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING ONES WAS CONFIRMED IN PATIENT MEDICAL RECORDS: PELVIC PAIN, FATIGUE, MENOMETRORRHAGIA, MENORRHAGIA, PSORIASIS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-SEP-2019: PFS AND MR WAS RECEIVED. LOT NUMBER (627097), NEW EVENTS: HOT FLASHES, MOOD SWINGS, ABNORMAL BLEEDING, NEW REPORTERS, PATIENT DEMOGRAPHIC INFORMATION, MEDICAL HISTORY, CONCOMITANT CONDITIONS AND DRUGS 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION'), MENOMETRORRHAGIA ('ABNORMAL BLEEDING: HEAVY FLOW AND PASSAGE OF CLOTS, MENSES OCCURING EVERY 2-3 WEEKS AVERAGING 10-14 DAYS IN DURATION') AND MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627097) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PAP SMEAR ABNORMAL, KIDNEY STONES, CERVICAL DYSPLASIA, ASTHMA, HYPERTENSION AND MORBID OBESITY. CONCURRENT CONDITIONS INCLUDED ANXIETY DISORDER, DEPRESSION, OVARIAN CYST, MENOMETRORRHAGIA, UTERINE LEIOMYOMA, FREQUENCY OF MENSES, STRESS, PNEUMONIA, MYOCARDIAL INFARCTION, UTERINE BLEEDING, LOW BACK PAIN, CONSTIPATION AND UTERINE FIBROID. CONCOMITANT PRODUCTS INCLUDED APREMILAST (OTEZLA), DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), DIAZEPAM (VALIUM), DILTIAZEM, FERROUS ASPARTO GLYCINATE;FERROUS FUMARATE (TANDEM), IBUPROFEN AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/ LOSS( SPECIFY WHICH ONE ) WEIGHT GAIN"). IN 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2016, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), PSORIASIS ("AUTOIMMUNE DISORDER-TYPE OF DISORDER: PLAQUE PSORAISIS"), HOT FLUSH ("HOT FLASHES"), MOOD SWINGS ("MOOD SWINGS") AND VAGINAL HAEMORRHAGE ("VAGINAL HEMORRHAGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENOMETRORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN, RIGHT SIDE PAIN"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE BLOOD URINE PRESENT ("BLADDER PROBLEMS OR CHANGES: BLOOD IN URINE") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND SALPINGECTOMY BILATERAL, HYSTERECTOMY FULL OOPHORECTOMY BILATERAL REMOVAL OF OVARIES). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PSORIASIS, BLOOD URINE PRESENT, URINARY TRACT DISORDER, HORMONE LEVEL ABNORMAL, FATIGUE, ALOPECIA, WEIGHT INCREASED, HOT FLUSH, MOOD SWINGS AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE MENOMETRORRHAGIA, MENORRHAGIA, PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BLOOD URINE PRESENT, DEVICE DISLOCATION, FATIGUE, HORMONE LEVEL ABNORMAL, HOT FLUSH, MENOMETRORRHAGIA, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN, PSORIASIS, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR FOLLOWING EVENTS PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), PLAQUE PSORIASIS, MIGRATION, BLADDER PROBLEMS, URINARY PROBLEMS, HORMONAL CHANGES, FATIGUE, HAIR LOSS, WEIGHT GAIN. CURRENT WEIGHT 220 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 70.9 KG/SQM. IMAGING PROCEDURE - ON (B)(6) 2009: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING ONES WAS CONFIRMED IN PATIENT MEDICAL RECORDS: PELVIC PAIN, FATIGUE, MENOMETRORRHAGIA, MENORRHAGIA, PSORIASIS. LOT NUMBER:627097 MANUFACTURE DATE:2008/04 EXPIRATION DATE:2010/04 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-JAN-2020: PFS RECEIVED EVENT " BLADDER OR URINARY PROBLEMS CHANGES: BLOOD IN URINE" WAS UPDATED. MEDICAL HISTORY AND PATIENT DEMOGRAPHICS WERE 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 ('MIGRATION') 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) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), PSORIASIS ("PLAQUE PSORAISIS"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY BILATERAL, HYSTERECTOMY FULL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PSORIASIS, BLADDER DISORDER, URINARY TRACT DISORDER, HORMONE LEVEL ABNORMAL, FATIGUE, ALOPECIA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ABDOMINAL PAIN AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BLADDER DISORDER, DEVICE DISLOCATION, FATIGUE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, PELVIC PAIN, PSORIASIS, URINARY TRACT DISORDER AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR FOLLOWING EVENTS PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), PLAQUE PSORIASIS, MIGRATION, BLADDER PROBLEMS, URINARY PROBLEMS, HORMONAL CHANGES, FATIGUE, HAIR LOSS, WEIGHT GAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2009: BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-AUG-2019: PLAINTIFF FACT SHEET WAS RECEIVED. EVENT INJURY WAS UPDATED TO FOLLOWING EVENTS: PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), PLAQUE PSORIASIS, MIGRATION, BLADDER PROBLEMS, URINARY PROBLEMS, HORMONAL CHANGES, FATIGUE, HAIR LOSS AND WEIGHT GAIN. ESSURE IMPLANT AND EXPLANT DATE ADDED. OUTCOME FOR EVENTS PELVIC PAIN, ABDOMINAL PAIN AND MENORRHAGIA (HEAVY MENSTRUAL BLEEDING) WERE RESOLVED. 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 |
|---|---|---|---|---|---|---|---|
| 757421 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 627097 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DILTIAZEM| DILTIAZEM| DILTIAZEM| FARXIGA| FARXIGA| FARXIGA| IBUPROFEN| IBUPROFEN| IBUPROFEN| OTEZLA| OTEZLA| OTEZLA| TANDEM| TANDEM| TANDEM| VALIUM| VALIUM| VALIUM |