ESSURE
Report
- Report Number
- 2951250-2023-03117
- Event Type
- Injury
- Date Received
- October 19, 2023
- Date of Event
- January 30, 2019
- Report Date
- January 26, 2024
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") IN A 46 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 646526) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. CONCOMITANT PRODUCTS INCLUDED LOSARTAN, PRIMPERAN (METOCLOPRAMIDE HYDROCHLORIDE), FUROSEMIDE, ETORICOXIB, DICLOFENAC, DEFLACORT (DEFLAZACORT), DIAZEPAM, ANTALGIN [NAPROXEN SODIUM], DOGMATIL (SULPIRIDE), EZITA (EZETIMIBE), IBUPROFEN AND TRANKIMAZIN (ALPRAZOLAM) FOR ANXIETY AND HYPERTENSION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, 988 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED SHOULDER INJURY ("INJURY IN THE RIGHT SHOULDER REGION WITH SIGNS OF BENIGNITY"). ON (B)(6) 2014 SHE EXPERIENCED NORMOCYTIC ANAEMIA ("NORMOCYTIC NORMOCHROMIC ANEMIA"). ON (B)(6) 2014 SHE WAS FOUND TO HAVE SERUM FERRITIN DECREASED ("ANEMIA WITH LOW FE PARAMETERS"). ON (B)(6) 2014 SHE EXPERIENCED PAIN IN EXTREMITY ("PAIN IN SOLE ON THE RIGHT FEET "), TENDON PAIN ("PAIN N THE ACHILLES TENDON") AND DYSURIA ("ITCHING WHEN URINATING NEGATIVE MULTISIX"). ON (B)(6) 2014 SHE EXPERIENCED VULVOVAGINAL PRURITUS ("VAGINAL ITCHING"). ON (B)(6) 2015 SHE EXPERIENCED VULVOVAGINAL CANDIDIASIS ("VAGINAL CANDIDA INFECTION"). ON (B)(6) 2015 SHE EXPERIENCED FOOT INJURY ("SERIOUS DISCHARGE FROM THE THUMB OF THE FEET"). ON (B)(6) 2016 SHE EXPERIENCED HYPOAESTHESIA ("NUMBNESS OF HANDS PRIMANLY IN RIGHT HAND"). ON (B)(6) 2016 SHE EXPERIENCED ARTHRALGIA ("PAIN IN THE RIGHT THIGH THAT GOES TO THE KNEE / PAIN IN THE RIGHT HAND JOINT"). ON (B)(6) 2016 SHE EXPERIENCED EYELID INJURY ("INJURY TO THE LEFT LOWER EYELID"). ON (B)(6) 2016 SHE EXPERIENCED VAGINAL DISCHARGE ("LEUKORRHEA") AND GENITAL PRURITUS FEMALE ("PRURITUS IN THE CERVIX"). ON (B)(6) 2016 SHE EXPERIENCED VERTIGO ("UNCOMPLICATE PERIPHERAL VERTIGO"). ON (B)(6) 2017 SHE EXPERIENCED GENITAL ITCHING ("GENITAL ITCHING"). ON (B)(6) 2017 SHE EXPERIENCED VULVOVAGINAL MYCOTIC INFECTION ("FUNGAL VULVOVAGINITIS"). ON (B)(6) 2018 SHE EXPERIENCED EPICONDYLITIS ("PAIN IN THE RIGHT ELBOW WITH EPITROCHLEITIS"). ON (B)(6) 2018 SHE EXPERIENCED PARONYCHIA ("PERIUNGUAL INJURY"). ON (B)(6) 2018 SHE EXPERIENCED MALAISE ("GENERAL MALAISE"), OROPHARYNGEAL PAIN ("THROAT PAIN"), HEADACHE ("HEADACHE") AND PHARYNGEAL ERYTHEMA ("PHARYNGEAL ERYTHEMA"). ON (B)(6) 2019 SHE EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE ("HEMORRHAGES"). ON (B)(6) 2019 SHE EXPERIENCED INTERMENSTRUAL BLEEDING ("METRORRHAGIA"), HEAVY MENSTRUAL BLEEDING ("HEAVY PERIODS") AND ADENOMYOSIS ("ADENOMYOSIS UTERUS"). ON (B)(6) 2019 SHE EXPERIENCED NAIL DISORDER ("SURGERY DUE TO A NAIL TUMOR ON THE 3RD FINGER OF THE RIGT HAND "). ON (B)(6) 2019 SHE EXPERIENCED INCISION SITE OEDEMA ("SEVERE PAIN IN IN RIGHT FINGER AND SLIGHT EDEMA IN THE SURGICAL WOUND PRESENT") AND DIZZINESS ("DIZZINESS"). ESSURE WAS REMOVED ON (B)(6) 2020. ON UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), FATIGUE ("FATIGUE"), BACK PAIN ("BACK PAIN"), ALOPECIA ("HAIR LOSS"), ADNEXA UTERI PAIN ("PAIN IN THE RIGHT OVARY THAT RADIATES TO THE GROIN"), LIMB DISCOMFORT ("HEAVINESS IN THE LEGS"), ANAEMIA ("ANEMIA"), ANXIETY ("ANXIETY") AND DEPRESSION ("DEPRESSION"). THE PATIENT WAS TREATED WITH AMOXICILLIN CLAVULANIC ACID (AMOXICILLIN TRIHYDRATE;CLAVULANATE POTASSIUM), AMOXICILIN RAP (AMOXICILLIN) AND IRON AS WELL AS SURGERY (TOTAL HYSTERECTOMY AND LAPAROSCOPIC BILATERAL ADNEXECTOMY). AT THE TIME OF THE REPORT, THE OUTCOMES FOR ABDOMINAL PAIN, SHOULDER INJURY, NORMOCYTIC ANAEMIA, SERUM FERRITIN DECREASED, PAIN IN EXTREMITY, TENDON PAIN, DYSURIA, VULVOVAGINAL PRURITUS, VULVOVAGINAL CANDIDIASIS, FOOT INJURY, HYPOAESTHESIA, ARTHRALGIA, EYELID INJURY, VAGINAL DISCHARGE, GENITAL PRURITUS FEMALE, VERTIGO, GENITAL ITCHING, VULVOVAGINAL MYCOTIC INFECTION, EPICONDYLITIS, PARONYCHIA, MALAISE, OROPHARYNGEAL PAIN, HEADACHE, PHARYNGEAL ERYTHEMA, GENITAL HAEMORRHAGE, INTERMENSTRUAL BLEEDING, HEAVY MENSTRUAL BLEEDING, ADENOMYOSIS, NAIL DISORDER, INCISION SITE OEDEMA, PELVIC PAIN, FATIGUE, BACK PAIN, ALOPECIA, ADNEXA UTERI PAIN, LIMB DISCOMFORT, ANAEMIA, ANXIETY AND DEPRESSION WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADENOMYOSIS, ADNEXA UTERI PAIN, ALOPECIA, ANAEMIA, ANXIETY, ARTHRALGIA, BACK PAIN, DEPRESSION, DIZZINESS, DYSURIA, EPICONDYLITIS, EYELID INJURY, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HYPOAESTHESIA, INCISION SITE OEDEMA, INTERMENSTRUAL BLEEDING, LIMB DISCOMFORT, SHOULDER INJURY, FOOT INJURY, MALAISE, NAIL DISORDER, NORMOCYTIC ANAEMIA, OROPHARYNGEAL PAIN, PAIN IN EXTREMITY, PARONYCHIA, PELVIC PAIN, PHARYNGEAL ERYTHEMA, GENITAL PRURITUS FEMALE, GENITAL ITCHING, SERUM FERRITIN DECREASED, TENDON PAIN, VAGINAL DISCHARGE, VERTIGO, VULVOVAGINAL CANDIDIASIS, VULVOVAGINAL MYCOTIC INFECTION AND VULVOVAGINAL PRURITUS TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [FULL BLOOD COUNT] ON (B)(6) 2013: ERYTHROCYTES: 3.89. HEMOGLOBIN: 10.2 G/DL, HEMATOCRIT: 32.8%. NEUTROPHILS: 74.2; ON (B)(6) 2014: ERYTROCYTES: 3.75, HEMOGLOBIN: 9.9, HEMATOCRIT: 31.4. FERRUM: 16.MCG/DL; ON (B)(6) 2014: ERYTHROCYTES: 3.99 MILL/MM3, HEMOGLOBIN: 11.6 G/DL, HEMATOCRIT: 35.3%, FERRUM: 34.0 MCG/DL. FERRITIN: 14 NG/ML; ON (B)(6) 2015: ERYTHROCYTES: 3.69 MILL/MM3, HEMOGLOBIN: 10 G/DL, HEMATOCRIT: 31%, FERRUM: 27 MCG/DL. FERRITIN: 14NG/M; ON (B)(6) 2016: ERYTHROCYTES: 3.82 MILL/MM3, HEMOGLOBIN: 10.8 G/DL, HEMATOCRIT: 32.6%. FERRITIN: 10NG/ML; ON (B)(6) 2016: ERYTHROCYTES: 3.93 MILL/MM3, HEMOGLOBIN: 11.7 G/DL, HEMATOCRIT: 34.8%. TTPA: 0.9; ON (B)(6) 2018: ERYTHROCYTES: 3.75, HEMOGLOBIN: 9.0 G/DL, HEMATOCRIT: 29.3 %, VCM: 78.0MCGM3, HCM: 24 PG. CHCM 30.8G/DL; ON (B)(6) 2019: ERTTHROCYTES 3.93 MILL/MM3, HEMOGLOBIN 10.6 G/DL, HEMATOCRIT 33.2%. FERRITIN 10NG/ML; ON (B)(6) 2019: HEMATOCRIT 35.1% HEMOGLOBIN 11.9 G/DL LYMPHOCYTES: 16.90% NEUTROPHILS: 74.20%; ON (B)(6) 2020: ERYTHROCYTES: 3.55 HEMOGLOBIN: 10.2 G/DL HEMATOCRIT: 30.06 % LYMPHOCYTES: 13.3% NEUTROPHILS: 78.1%; ON (B)(6) 2021: HEMOGLOBIN: 11.6 G/DL HEMATOCRIT: 35.3%. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: 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. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 25-JAN-2024: 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") IN A 46 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 646526) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. CONCOMITANT PRODUCTS INCLUDED LOSARTAN, PRIMPERAN (METOCLOPRAMIDE HYDROCHLORIDE), FUROSEMIDE, ETORICOXIB, DICLOFENAC, DEFLACORT (DEFLAZACORT), DIAZEPAM, ANTALGIN [NAPROXEN SODIUM], DOGMATIL (SULPIRIDE), EZITA (EZETIMIBE), IBUPROFEN AND TRANKIMAZIN (ALPRAZOLAM) FOR ANXIETY AND HYPERTENSION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, 988 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED SHOULDER INJURY ("INJURY IN THE RIGHT SHOULDER REGION WITH SIGNS OF BENIGNITY"). ON (B)(6) 2014 SHE EXPERIENCED NORMOCYTIC ANAEMIA ("NORMOCYTIC NORMOCHROMIC ANEMIA"). ON (B)(6) 2014 SHE WAS FOUND TO HAVE SERUM FERRITIN DECREASED ("ANEMIA WITH LOW FE PARAMETERS"). ON (B)(6) 2014 SHE EXPERIENCED PAIN IN EXTREMITY ("PAIN IN SOLE ON THE RIGHT FEET "), TENDON PAIN ("PAIN N THE ACHILLES TENDON") AND DYSURIA ("ITCHING WHEN URINATING NEGATIVE MULTISIX"). ON (B)(6) 2014 SHE EXPERIENCED VULVOVAGINAL PRURITUS ("VAGINAL ITCHING"). ON (B)(6) 2015 SHE EXPERIENCED VULVOVAGINAL CANDIDIASIS ("VAGINAL CANDIDA INFECTION"). ON (B)(6) 2015 SHE EXPERIENCED FOOT INJURY ("SERIOUS DISCHARGE FROM THE THUMB OF THE FEET"). ON (B)(6) 2016 SHE EXPERIENCED HYPOAESTHESIA ("NUMBNESS OF HANDS PRIMANLY IN RIGHT HAND"). ON (B)(6) 2016 SHE EXPERIENCED ARTHRALGIA ("PAIN IN THE RIGHT THIGH THAT GOES TO THE KNEE / PAIN IN THE RIGHT HAND JOINT"). ON (B)(6) 2016 SHE EXPERIENCED EYELID INJURY ("INJURY TO THE LEFT LOWER EYELID"). ON (B)(6) 2016 SHE EXPERIENCED VAGINAL DISCHARGE ("LEUKORRHEA") AND PRURITUS ("PRURITUS IN THE CERVIX"). ON (B)(6) 2016 SHE EXPERIENCED VERTIGO ("UNCOMPLICATE PERIPHERAL VERTIGO"). ON (B)(6) 2017 SHE EXPERIENCED PRURITUS GENITAL ("GENITAL ITCHING"). ON (B)(6) 2017 SHE EXPERIENCED VULVOVAGINAL MYCOTIC INFECTION ("FUNGAL VULVOVAGINITIS"). ON (B)(6) 2018 SHE EXPERIENCED EPICONDYLITIS ("PAIN IN THE RIGHT ELBOW WITH EPITROCHLEITIS"). ON (B)(6) 2018 SHE EXPERIENCED PARONYCHIA ("PERIUNGUAL INJURY"). ON (B)(6) 2018 SHE EXPERIENCED MALAISE ("GENERAL MALAISE"), OROPHARYNGEAL PAIN ("THROAT PAIN"), HEADACHE ("HEADACHE") AND PHARYNGEAL ERYTHEMA ("PHARYNGEAL ERYTHEMA"). ON (B)(6) 2019 SHE EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE ("HEMORRHAGES"). ON (B)(6) 2019 SHE EXPERIENCED INTERMENSTRUAL BLEEDING ("METRORRHAGIA"), HEAVY MENSTRUAL BLEEDING ("HEAVY PERIODS") AND ADENOMYOSIS ("ADENOMYOSIS UTERUS"). ON (B)(6) 2019 SHE EXPERIENCED NAIL DISORDER ("SURGERY DUE TO A NAIL TUMOR ON THE 3RD FINGER OF THE RIGT HAND "). ON (B)(6) 2019 SHE EXPERIENCED OEDEMA PERIPHERAL ("SEVERE PAIN IN IN RIGHT FINGER AND SLIGHT EDEMA IN THE SURGICAL WOUND PRESENT") AND DIZZINESS ("DIZZINESS"). AT AN UNKNOWN TIME, SHE EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), FATIGUE ("FATIGUE"), BACK PAIN ("BACK PAIN"), ALOPECIA ("HAIR LOSS"), ADNEXA UTERI PAIN ("PAIN IN THE RIGHT OVARY THAT RADIATES TO THE GROIN"), LIMB DISCOMFORT ("HEAVINESS IN THE LEGS"), ANAEMIA ("ANEMIA"), ANXIETY ("ANXIETY") AND DEPRESSION ("DEPRESSION"). THE PATIENT WAS TREATED WITH AMOXICILLIN CLAVULANIC ACID (AMOXICILLIN TRIHYDRATE;CLAVULANATE POTASSIUM), AMOXICILIN RAP (AMOXICILLIN) AND IRON AS WELL AS SURGERY (TOTAL HYSTERECTOMY AND LAPAROSCOPIC BILATERAL ADNEXECTOMY). AT THE TIME OF THE REPORT, THE OUTCOMES FOR ABDOMINAL PAIN, SHOULDER INJURY, NORMOCYTIC ANAEMIA, SERUM FERRITIN DECREASED, PAIN IN EXTREMITY, TENDON PAIN, DYSURIA, VULVOVAGINAL PRURITUS, VULVOVAGINAL CANDIDIASIS, FOOT INJURY, HYPOAESTHESIA, ARTHRALGIA, EYELID INJURY, VAGINAL DISCHARGE, PRURITUS, VERTIGO, PRURITUS GENITAL, VULVOVAGINAL MYCOTIC INFECTION, EPICONDYLITIS, PARONYCHIA, MALAISE, OROPHARYNGEAL PAIN, HEADACHE, PHARYNGEAL ERYTHEMA, GENITAL HAEMORRHAGE, INTERMENSTRUAL BLEEDING, HEAVY MENSTRUAL BLEEDING, ADENOMYOSIS, NAIL DISORDER, OEDEMA PERIPHERAL, PELVIC PAIN, FATIGUE, BACK PAIN, ALOPECIA, ADNEXA UTERI PAIN, LIMB DISCOMFORT, ANAEMIA, ANXIETY AND DEPRESSION WERE UNKNOWN. ESSURE WAS REMOVED ON (B)(6) 2020. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADENOMYOSIS, ADNEXA UTERI PAIN, ALOPECIA, ANAEMIA, ANXIETY, ARTHRALGIA, BACK PAIN, DEPRESSION, DIZZINESS, DYSURIA, EPICONDYLITIS, EYELID INJURY, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HYPOAESTHESIA, INTERMENSTRUAL BLEEDING, LIMB DISCOMFORT, SHOULDER INJURY, FOOT INJURY, MALAISE, NAIL DISORDER, NORMOCYTIC ANAEMIA, OEDEMA PERIPHERAL, OROPHARYNGEAL PAIN, PAIN IN EXTREMITY, PARONYCHIA, PELVIC PAIN, PHARYNGEAL ERYTHEMA, PRURITUS, PRURITUS GENITAL, SERUM FERRITIN DECREASED, TENDON PAIN, VAGINAL DISCHARGE, VERTIGO, VULVOVAGINAL CANDIDIASIS, VULVOVAGINAL MYCOTIC INFECTION AND VULVOVAGINAL PRURITUS TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [FULL BLOOD COUNT] ON (B)(6) 2013: ERYTHROCYTES: 3.89. HEMOGLOBIN: 10.2 G/DL. HEMATOCRIT: 32.8%. NEUTROPHILS: 74.2; ON (B)(6) 2014: ERYTROCYTES: 3.75. HEMOGLOBIN: 9.9. HEMATOCRIT: 31.4. FERRUM: 16.MCG/DL; ON (B)(6) 2014: ERYTHROCYTES: 3.99 MILL/MM3. HEMOGLOBIN: 11.6 G/DL. HEMATOCRIT: 35.3%. FERRUM: 34.0 MCG/DL. FERRITIN: 14 NG/ML; ON (B)(6) 2015: ERYTHROCYTES: 3.69 MILL/MM3. HEMOGLOBIN: 10 G/DL. HEMATOCRIT: 31%. FERRUM: 27 MCG/DL. FERRITIN: 14NG/M; ON (B)(6) 2016: ERYTHROCYTES: 3.82 MILL/MM3. HEMOGLOBIN: 10.8 G/DL. HEMATOCRIT: 32.6%. FERRITIN: 10NG/ML; ON (B)(6) 2016: ERYTHROCYTES: 3.93 MILL/MM3. HEMOGLOBIN: 11.7 G/DL. HEMATOCRIT: 34.8%. TTPA: 0.9; ON (B)(6) 2018: ERYTHROCYTES: 3.75. HEMOGLOBIN: 9.0 G/DL. HEMATOCRIT: 29.3 %. VCM: 78.0MCGM3. HCM: 24 PG. CHCM 30.8G/DL; ON (B)(6) 2019: ERTTHROCYTES 3.93 MILL/MM3. HEMOGLOBIN 10.6 G/DL. HEMATOCRIT 33.2%. FERRITIN 10NG/ML; ON (B)(6) 2019: HEMATOCRIT 35.1%. HEMOGLOBIN 11.9 G/DL. LYMPHOCYTES: 16.90%. NEUTROPHILS: 74.20%; ON (B)(6) 2020: ERYTHROCYTES: 3.55. HEMOGLOBIN: 10.2 G/DL. HEMATOCRIT: 30.06 %. LYMPHOCYTES: 13.3%. NEUTROPHILS: 78.1%; ON (B)(6) 2021: HEMOGLOBIN: 11.6 G/DL. HEMATOCRIT: 35.3%. 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 |
|---|---|---|---|---|---|---|---|
| 95071 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 646526 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Female | Required Intervention | ANTALGIN [NAPROXEN SODIUM]| ANTALGIN [NAPROXEN SODIUM]| DEFLACORT| DEFLACORT| DIAZEPAM| DIAZEPAM| DICLOFENAC| DICLOFENAC| DOGMATIL| DOGMATIL| ETORICOXIB| ETORICOXIB| EZITA| EZITA| FUROSEMIDE| FUROSEMIDE| IBUPROFEN| IBUPROFEN| LOSARTAN| LOSARTAN| PRIMPERAN| PRIMPERAN| TRANKIMAZIN| TRANKIMAZIN |