ESSURE
Report
- Report Number
- 2951250-2019-10321
- Event Type
- Injury
- Date Received
- October 16, 2019
- Date of Event
- March 1, 2012
- Report Date
- April 21, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN,CHRONIC'), APPENDICECTOMY ('SHORTLY AFTER MY APPENDIX') AND CHOLECYSTECTOMY ('GALBLADDER PROBLEMS') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910515) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED VITAMIN D [VITAMIN D NOS]. THE PATIENT'S MEDICAL HISTORY INCLUDED POLYPS IN 2008, SINUS OPERATION IN 2008, MORBID OBESITY AND FLUID RETENTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PARAGARD. CONCURRENT CONDITIONS INCLUDED VAGINAL BLEEDING AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN) FROM (B)(6) OF 2012 TO (B)(6) OF 2014 FOR DEPRESSION AS WELL AS AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HCL) FROM (B)(6) OF 2012 TO (B)(6) OF 2014, DIAZEPAM (VALIUM) FROM (B)(6) OF 2012 TO (B)(6) OF 2014, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN) SINCE 2008, IBUPROFEN SINCE 2008, NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) FROM (B)(6) OF 2012 TO (B)(6) OF 2014 AND TRAMADOL IN (B)(6) OF 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT STARTED VITAMIN D [VITAMIN D NOS] AT AN UNSPECIFIED DOSE AND FREQUENCY. IN (B)(6) OF 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING), FATIGUE ("FATIGUE"), ABDOMINAL DISTENSION ("GI CONDITIONS,GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"), HEADACHE ("HEADACHES"), DYSGEUSIA ("METALLIC TASTE,OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: METALLIC TASTE IN MOUTH"), BACK PAIN ("LOW BACK PAIN") AND RASH ("RASHES OR SKIN CONDITIONS TYPE: RASH ON ARMS AND FACE"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), 6 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) OF 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI,INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI,"), NAUSEA ("NAUSEA") AND FEELING ABNORMAL ("BRAIN FOG") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) OF 2018, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) OF 2018, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). ON (B)(6) 2018, THE PATIENT EXPERIENCED GENERALISED OEDEMA ("SYSTEMIC EDEMA"), ENDOMETRIOSIS ("ENDOMETRIOSIS.") AND CERVICAL CYST ("BENIGN ECTO/ENDOCERVIX WITH MULTIPLE NABOTHIAN CYSTS."). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT APPENDICECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND CHOLECYSTECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED GENITAL HAEMORRHAGE ("GEN. ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), CYSTITIS ("BLADDER INFECTION"), MIGRAINE ("MIGRAINE") AND FIBROMYALGIA ("FIBROMYALGIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, APPENDIX REMOVAL AND GALLBLADDER REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FATIGUE AND WEIGHT INCREASED WAS RESOLVING, THE APPENDICECTOMY, CHOLECYSTECTOMY, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, ALLERGY TO METALS, CYSTITIS, MIGRAINE, HEADACHE, GENERALISED OEDEMA, ENDOMETRIOSIS AND CERVICAL CYST OUTCOME WAS UNKNOWN, THE URINARY TRACT INFECTION, ABDOMINAL DISTENSION, TOOTH DISORDER, NAUSEA, FEELING ABNORMAL, DYSGEUSIA, VAGINAL HAEMORRHAGE, BACK PAIN AND RASH HAD RESOLVED AND THE FIBROMYALGIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, APPENDICECTOMY, BACK PAIN, CERVICAL CYST, CHOLECYSTECTOMY, CYSTITIS, DYSGEUSIA, DYSMENORRHOEA, ENDOMETRIOSIS, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, GENERALISED OEDEMA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, RASH, TOOTH DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PAIN ,BLEEDING, ALLERGY ,BLADDER/URINARY PROBLEM AND OTHER INJURIES/SYMPTOM. RIGHT -8 COILS. LEFT- 3 COILS . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 49.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2012: RESULTS OF CONFIRM. TEST BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS CONFIRMING: MENORRHAGIA, NICKEL ALLERGY, ENDOMETRIOSIS, SYSTEMIC EDEMA, CYST CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: GALLBLADDER DISORDER, APPENDIX DISORDER . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PFS RECEIVED: (SOCIAL MEDIA); NEW EVENTS GALLBLADDER REMOVED, SHORTLY AFTER MY APPENDIX WERE ADDED. REPORTER 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 PELVIC PAIN ('PELVIC PAIN,CHRONIC'), APPENDICECTOMY ('SHORTLY AFTER MY APPENDIX') AND CHOLECYSTECTOMY ('GALBLADDER PROBLEMS') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910515) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED VITAMIN D [VITAMIN D NOS]. THE PATIENT'S MEDICAL HISTORY INCLUDED POLYPS IN 2008, SINUS OPERATION IN 2008, MORBID OBESITY AND FLUID RETENTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PARAGARD. CONCURRENT CONDITIONS INCLUDED VAGINAL BLEEDING AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN) FROM (B)(6) 2012 TO (B)(6) 2014 FOR DEPRESSION AS WELL AS AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HCL) FROM (B)(6) 2012 TO (B)(6) 2014, DIAZEPAM (VALIUM) FROM (B)(6) 2012 TO (B)(6) 2014, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN) SINCE 2008, IBUPROFEN SINCE 2008, NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) FROM (B)(6) 2012 TO (B)(6) 2014 AND TRAMADOL IN (B)(6) 2012. ON AN UNKNOWN DATE, THE PATIENT STARTED VITAMIN D [VITAMIN D NOS] AT AN UNSPECIFIED DOSE AND FREQUENCY. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)"), FATIGUE ("FATIGUE"), ABDOMINAL DISTENSION ("GI CONDITIONS,GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"), HEADACHE ("HEADACHES"), DYSGEUSIA ("METALLIC TASTE,OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: METALLIC TASTE IN MOUTH"), BACK PAIN ("LOW BACK PAIN") AND RASH ("RASHES OR SKIN CONDITIONS TYPE: RASH ON ARMS AND FACE"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), 6 DAYS AFTER INSERTION OF ESSURE. IN APRIL 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI,INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI,"), NAUSEA ("NAUSEA") AND FEELING ABNORMAL ("BRAIN FOG") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2018, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2018, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). ON (B)(6) 2018, THE PATIENT EXPERIENCED GENERALISED OEDEMA ("SYSTEMIC EDEMA"), ENDOMETRIOSIS ("ENDOMETRIOSIS.") AND CERVICAL CYST ("BENIGN ECTO/ENDOCERVIX WITH MULTIPLE NABOTHIAN CYSTS."). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT APPENDICECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND CHOLECYSTECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED GENITAL HAEMORRHAGE ("GEN. ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), CYSTITIS ("BLADDER INFECTION"), MIGRAINE ("MIGRAINE"), FIBROMYALGIA ("FIBROMYALGIA"), ALOPECIA ("HAIR LOSS") AND TOOTH LOSS ("TOOTH LOSS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, APPENDIX REMOVAL AND GALLBLADDER REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FATIGUE AND WEIGHT INCREASED WAS RESOLVING, THE APPENDICECTOMY, CHOLECYSTECTOMY, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, ALLERGY TO METALS, CYSTITIS, MIGRAINE, HEADACHE, GENERALISED OEDEMA, ENDOMETRIOSIS, CERVICAL CYST, ALOPECIA AND TOOTH LOSS OUTCOME WAS UNKNOWN, THE URINARY TRACT INFECTION, ABDOMINAL DISTENSION, TOOTH DISORDER, NAUSEA, FEELING ABNORMAL, DYSGEUSIA, VAGINAL HAEMORRHAGE, BACK PAIN AND RASH HAD RESOLVED AND THE FIBROMYALGIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, APPENDICECTOMY, BACK PAIN, CERVICAL CYST, CHOLECYSTECTOMY, CYSTITIS, DYSGEUSIA, DYSMENORRHOEA, ENDOMETRIOSIS, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, GENERALISED OEDEMA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, RASH, TOOTH DISORDER, TOOTH LOSS, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PAIN ,BLEEDING, ALLERGY ,BLADDER/URINARY PROBLEM AND OTHER INJURIES/SYMPTOM. RIGHT -8 COILS, LEFT- 3 COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 49.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2012: RESULTS OF CONFIRM. TEST BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS CONFIRMING: MENORRHAGIA, NICKEL ALLERGY, ENDOMETRIOSIS, SYSTEMIC EDEMA, CYST CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: GALLBLADDER DISORDER, APPENDIX DISORDER,TOOTH LOSS AND HAIR LOSS . LOT NUMBER:910515 MANUFACTURING DATE:2011-10 EXPIRATION DATE:2014-10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA RECEIVED. REPORTER'S INFORMATION ADDED.EVENT: TOOTH LOSS AND HAIR LOSS 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 PELVIC PAIN ('PELVIC PAIN,CHRONIC') AND GENITAL HAEMORRHAGE ('GEN. ABNORMAL BLEEDING') IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910515) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED VITAMIN D [VITAMIN D NOS]. THE PATIENT'S MEDICAL HISTORY INCLUDED POLYPS IN 2008, SINUS OPERATION IN 2008, OVERWEIGHT AND FLUID RETENTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PARAGARD. CONCURRENT CONDITIONS INCLUDED VAGINAL BLEEDING AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN) FROM (B)(6) 2012 TO (B)(6) 2014 FOR DEPRESSION AS WELL AS AMITRIPTYLINE FROM (B)(6) 2012 TO (B)(6) 2014, DIAZEPAM (VALIUM) FROM (B)(6) 2012 TO (B)(6) 2014, HYDROCODONE BITARTRATE; PARACETAMOL (VICODIN) SINCE 2008, IBUPROFEN SINCE 2008, NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) FROM (B)(6) 2012 TO (B)(6) 2014 AND TRAMADOL IN (B)(6) 2012. ON AN UNKNOWN DATE, THE PATIENT STARTED VITAMIN D [VITAMIN D NOS] AT AN UNSPECIFIED DOSE AND FREQUENCY. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), ABDOMINAL DISTENSION ("GI CONDITIONS,GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"), HEADACHE ("HEADACHES"), DYSGEUSIA ("METALLIC TASTE,OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: METALLIC TASTE IN MOUTH"), BACK PAIN ("LOW BACK PAIN") AND RASH ("RASHES OR SKIN CONDITIONS TYPE: RASH ON ARMS AND FACE"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), 6 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI, INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI,"), NAUSEA ("NAUSEA") AND FEELING ABNORMAL ("NEURO CONDIT/PROB,NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: BRAIN FOG") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2018, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2018, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). ON (B)(6) 2018, THE PATIENT EXPERIENCED OEDEMA ("SYSTEMIC EDEMA"), ENDOMETRIOSIS ("ENDOMETRIOSIS.") AND CERVICAL CYST ("BENIGN ECTO/ENDOCERVIX WITH MULTIPLE NABOTHIAN CYSTS."). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), CYSTITIS ("BLADDER INFECTION"), MIGRAINE ("MIGRAINE") AND FIBROMYALGIA ("FIBROMYALGIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FATIGUE AND WEIGHT INCREASED WAS RESOLVING, THE GENITAL HAEMORRHAGE, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, ALLERGY TO METALS, CYSTITIS, MIGRAINE, HEADACHE, OEDEMA, ENDOMETRIOSIS AND CERVICAL CYST OUTCOME WAS UNKNOWN, THE URINARY TRACT INFECTION, ABDOMINAL DISTENSION, TOOTH DISORDER, NAUSEA, FEELING ABNORMAL, DYSGEUSIA, VAGINAL HAEMORRHAGE, BACK PAIN AND RASH HAD RESOLVED AND THE FIBROMYALGIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, BACK PAIN, CERVICAL CYST, CYSTITIS, DYSGEUSIA, DYSMENORRHOEA, ENDOMETRIOSIS, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, OEDEMA, PELVIC PAIN, RASH, TOOTH DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PAIN ,BLEEDING, ALLERGY ,BLADDER/URINARY PROBLEM AND OTHER INJURIES/SYMPTOM. RIGHT - 8 COILS. LEFT- 3 COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 49.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2012: RESULTS OF CONFIRM. TEST BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS CONFIRMING: MENORRHAGIA, NICKEL ALLERGY, ENDOMETRIOSIS, SYSTEMIC EDEMA, CYST . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-SEP-2019: PLAINTIFF FACT SHEET, REPORTER INFORMATION, NEW REPORTER, PATIENT DEMOGRAPHIC, LAB DATA, ESSURE INDICATION, START STOP DATE, PREVIOUS EVENT INJURY TO HERSELF DELETED AND NEW EVENT CHRONIC, DYSMENORRHEA (CRAMPING), PELVIC/ABDOMINAL, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),GEN. ABNORMAL BLEEDING, NICKEL ALLERGY, BLADDER INFECT., UTI, FATIGUE, GI CONDITIONS, DENTAL PROBS., MIGRAINE, HEADACHES, NAUSEA, NEURO CONDIT/PROB, WEIGHT GAIN, METALLIC TASTE AND OUTCOME WERE ADDED FU 02, 03 & 4 PROCESSED TOGETHER. ON 20-SEP-2019: PLAINTIFF FACT SHEET, REPORTER INFORMATION , NEW REPORTER, PATIENT DEMOGRAPHIC UPDATE, LAB DATA , PATIENT CONCOMITANT CONDITION ,MEDICATION AND NEW EVENT ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), LOW BACK PAIN, RASHES OR SKIN CONDITIONS TYPE: RASH ON ARMS AND FACE, SYSTEMIC EDEMA AND EVENT OUTCOME WERE ADDED. FOLLOW-UP 2 AND 3 PROCESSES TOGETHER. ON 26-SEP-2019: PLAINTIFF FACT SHEET RECEIVED. NO NEW INFORMATION UPDATED. INCIDENT: 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 992390 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 910515 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other| R | AMITRIPTYLINE HCL.| AMITRIPTYLINE HCL.| AMITRIPTYLINE.| IBUPROFEN.| IBUPROFEN.| IBUPROFEN.| NORETHINDRONE ACETATE.| NORETHINDRONE ACETATE.| NORETHINDRONE ACETATE.| TRAMADOL.| TRAMADOL.| TRAMADOL.| VALIUM.| VALIUM.| VALIUM.| VICODIN.| VICODIN.| VICODIN.| WELLBUTRIN.| WELLBUTRIN.| WELLBUTRIN. |