ESSURE
Report
- Report Number
- 2951250-2021-03248
- Event Type
- Injury
- Date Received
- September 28, 2021
- Date of Event
- January 1, 2013
- Report Date
- December 16, 2022
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY FDA (REFERENCE NUMBER: MW5103809) ON 24-SEP-2021. THE MOST RECENT INFORMATION WAS RECEIVED ON 15-NOV-2022. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND ANAEMIA ("ANEMIC") IN A 37 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 841531) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF NICKEL SENSITIVITY, ADENOMYOSIS, AUTOIMMUNE DISORDER, AMENORRHEA, POLYCYSTIC OVARIAN SYNDROME, ABNORMAL UTERINE BLEEDING, HEAVY MENSTRUAL BLEEDING AND IRREGULAR PERIODS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: PROCHLORPERAZINE. CONCOMITANT PRODUCTS INCLUDED VITAMINS NOS, CALCIUM, MAGNESIUM AND LEVOTHYROXINE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2013 SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), HYPOTHYROIDISM ("HYPOTHYROIDISM") AND GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("SEVERE WEIGHT GAIN"). ESSURE WAS REMOVED ON (B)(6) 2021. AN UNKNOWN TIME LATER SHE EXPERIENCED ALLERGY TO METALS ("ALLERGIC TO NICKEL"), ANAEMIA (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), ABDOMINAL PAIN ("ABDOMINA PAIN"), DYSMENORRHOEA ("PAINFUL PERIODS") AND INTERNAL HAEMORRHAGE ("INTERNAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY TO HAVE THE COILS REMOVED) AND NON-DRUG THERAPY (BLOOD TRANSFUSION). AT THE TIME OF THE REPORT, THE PELVIC PAIN AND HYPOTHYROIDISM HAD RESOLVED. THE OUTCOMES FOR WEIGHT INCREASED, GENITAL HAEMORRHAGE, ALLERGY TO METALS, ANAEMIA, ABDOMINAL PAIN, DYSMENORRHOEA AND INTERNAL HAEMORRHAGE WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANAEMIA, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HYPOTHYROIDISM, INTERNAL HAEMORRHAGE, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [PATHOLOGY TEST] ON (B)(6) 2021: SURGICAL PATHOLOGY REPORT: FINAL PATHOLOGIC DIAGNOSIS. UTERUS. CERVIX. BILATERAL FALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX: BENIGN ECTO- AND ENDOCERVICAL MUCOSA. ENDOMETRIUM: PROLIFERATIVE ENDOMETRIUM. MYOMETRIUM: PROMINENT ADENOMYOSIS. SEROSA: SEROSAL ADHESIONS. BILATERAL FALLOPIAN TUBES: PORTIONS OF TWO FALLOPIAN TUBES WITHOUT SIGNIFICANT HISTOPATHOLOGIC ABNORMALITY. CLINICAL HISTORY: PELVIC PAIN. SPECIMENS RECEIVED: UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES, GROSS DESCRIPTION: IDENTIFIED INVOLVING THE BILATERAL SEGMENTS OF BOTH PROXIMAL FALLOPIAN TUBES ARE GREY COIL METALLIC DEVICES CONSISTENT WITH ESSURE DEVICES. THEY AVERAGE 2.0 CM IN LENGTH AND 0.2 CM IN DIAMETER. [PREGNANCY TEST] ON (B)(6) 2021: NEGATIVE. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 15-NOV-2022: MEDICAL RECORD RECEIVED. LOT NUMBER ADDED. MEDICAL HISTORY & LAB DATA UPDATED. REPORTER INFORMATION UPDATED. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: MW5103809) ON 24-SEP-2021. THE MOST RECENT INFORMATION WAS RECEIVED ON 16-DEC-2022. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') AND ANAEMIA ('ANEMIC') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841531) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED IRREGULAR PERIODS, HEAVY MENSTRUAL BLEEDING, ABNORMAL UTERINE BLEEDING, POLYCYSTIC OVARIAN SYNDROME, AMENORRHEA, AUTOIMMUNE DISORDER, ADENOMYOSIS AND NICKEL SENSITIVITY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PROCHLORPERAZINE. CONCOMITANT PRODUCTS INCLUDED CALCIUM, LEVOTHYROXINE, MAGNESIUM AND VITAMINS NOS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HYPOTHYROIDISM ("HYPOTHYROIDISM") AND GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("SEVERE WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS ("ALLERGIC TO NICKEL"), ANAEMIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINA PAIN"), DYSMENORRHOEA ("PAINFULL PERIODS") AND INTERNAL HAEMORRHAGE ("INTERNAL BLEEDING"). THE PATIENT WAS TREATED WITH BLOOD TRANSFUSION AND SURGERY (HYSTERECTOMY TO HAVE THE COILS REMOVED). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND HYPOTHYROIDISM HAD RESOLVED AND THE WEIGHT INCREASED, GENITAL HAEMORRHAGE, ALLERGY TO METALS, ANAEMIA, ABDOMINAL PAIN, DYSMENORRHOEA AND INTERNAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANAEMIA, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HYPOTHYROIDISM, INTERNAL HAEMORRHAGE, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON (B)(6) 2021: SURGICAL PATHOLOGY REPORT: FINAL PATHOLOGIC DIAGNOSIS UTERUS. CERVIX. BILATERAL FALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX: BENIGN ECTO- AND ENDOCERVICAL MUCOSA. ENDOMETRIUM: PROLIFERATIVE ENDOMETRIUM. MYOMETRIUM: PROMINENT ADENOMYOSIS. SEROSA: SEROSAL ADHESIONS. BILATERAL FALLOPIAN TUBES: PORTIONS OF TWO FALLOPIAN TUBES WITHOUT SIGNIFICANT HISTOPATHOLOGIC ABNORMALITY. CLINICAL HISTORY: PELVIC PAIN. SPECIMENS RECEIVED: UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES. GROSS DESCRIPTION: IDENTIFIED INVOLVING THE BILATERAL SEGMENTS OF BOTH PROXIMAL FALLOPIAN TUBES ARE GREY COIL METALLIC DEVICES CONSISTENT WITH ESSURE DEVICES. THEY AVERAGE 2.0 CM IN LENGTH AND 0.2 CM IN DIAMETER.. PREGNANCY TEST - ON (B)(6) 2021: NEGATIVE. LOT NUMBER: 841531. MANUFACTURE DATE:2011-03. EXPIRATION DATE: 2014-03. 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-DEC-2022: 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: MW5103809) ON 24-SEP-2021. THE MOST RECENT INFORMATION WAS RECEIVED ON 29-SEP-2021 THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED CALCIUM, LEVOTHYROXINE, MAGNESIUM AND VITAMINS NOS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HYPOTHYROIDISM ("HYPOTHYROIDISM") AND GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("SEVERE WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS ("ALLERGIC TO NICKEL"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY TO HAVE THE COILS REMOVED). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND HYPOTHYROIDISM HAD RESOLVED AND THE WEIGHT INCREASED, GENITAL HAEMORRHAGE AND ALLERGY TO METALS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, GENITAL HAEMORRHAGE, HYPOTHYROIDISM, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-SEP-2021: 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.
THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY FDA (REFERENCE NUMBER: MW5103809) ON 24-SEP-2021. THE MOST RECENT INFORMATION WAS RECEIVED ON 22-APR-2022. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED 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 VITAMINS NOS, CALCIUM, MAGNESIUM AND LEVOTHYROXINE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2013 SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), HYPOTHYROIDISM ("HYPOTHYROIDISM") AND GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("SEVERE WEIGHT GAIN"). ESSURE WAS REMOVED ON (B)(6) 2021. AN UNKNOWN TIME LATER SHE EXPERIENCED ALLERGY TO METALS ("ALLERGIC TO NICKEL"), ANAEMIA ("ANEMIC"), ABDOMINAL PAIN ("ABDOMINA PAIN"), DYSMENORRHOEA ("PAINFUL PERIODS") AND INTERNAL HAEMORRHAGE ("INTERNAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY TO HAVE THE COILS REMOVED) AND NON-DRUG THERAPY (BLOOD TRANSFUSION). AT THE TIME OF THE REPORT, THE PELVIC PAIN AND HYPOTHYROIDISM HAD RESOLVED. THE OUTCOMES FOR WEIGHT INCREASED, GENITAL HAEMORRHAGE, ALLERGY TO METALS, ANAEMIA, ABDOMINAL PAIN, DYSMENORRHOEA AND INTERNAL HAEMORRHAGE WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANAEMIA, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HYPOTHYROIDISM, INTERNAL HAEMORRHAGE, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 22-APR-2022: PLAINTIFF FACT SHEET RECEIVED. EVENTS ANEMIA, ABDOMINAL PAIN , PAINFUL PERIODS & INTERNAL BLEEDING WERE ADDED. REPORTER INFORMATION UPDATED. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: MW5103809) ON 24-SEP-2021. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED CALCIUM, LEVOTHYROXINE, MAGNESIUM AND VITAMINS NOS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HYPOTHYROIDISM ("HYPOTHYROIDISM") AND GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("SEVERE WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS ("ALLERGIC TO NICKEL"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY TO HAVE THE COILS REMOVED). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND HYPOTHYROIDISM HAD RESOLVED AND THE WEIGHT INCREASED, GENITAL HAEMORRHAGE AND ALLERGY TO METALS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, GENITAL HAEMORRHAGE, HYPOTHYROIDISM, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. 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 |
|---|---|---|---|---|---|---|---|
| 1439953 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841531 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Required Intervention| O | CALCIUM.| CALCIUM.| CALCIUM.| CALCIUM.| CALCIUM.| LEVOTHYROXINE.| LEVOTHYROXINE.| LEVOTHYROXINE.| LEVOTHYROXINE.| LEVOTHYROXINE.| MAGNESIUM.| MAGNESIUM.| MAGNESIUM.| MAGNESIUM.| MAGNESIUM.| VITAMINS NOS.| VITAMINS NOS.| VITAMINS NOS.| VITAMINS NOS.| VITAMINS NOS.| CALCIUM| LEVOTHYROXINE| MAGNESIUM| VITAMINS NOS |