ESSURE
Report
- Report Number
- 2951250-2018-05101
- Event Type
- Injury
- Date Received
- December 6, 2018
- Date of Event
- January 1, 2015
- Report Date
- August 3, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION') AND NEOPLASM MALIGNANT ('CANCER') IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 382191(NOT VALID), 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST? NO". THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION, DEPRESSIVE DISORDER, INTERVERTEBRAL DISC BULGING, KIDNEY STONE, APPENDECTOMY, CHOLECYSTECTOMY AND ENDOMETRIAL ABLATION. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, DERMATITIS, BRONCHITIS, RASH, ABDOMINAL PAIN, FEELING UNWELL, VOMITING, MALAISE, LOSS OF CONSCIOUSNESS, DIZZINESS AGGRAVATED, CONFUSED, COUGH, ACUTE UPPER RESPIRATORY TRACT INFECTION, HYPERTENSION, SUICIDAL IDEATION, HEAD INJURY AND HYPERCHOLESTEREMIA. CONCOMITANT PRODUCTS INCLUDED CIPROFLOXACIN (CIPRO), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), IBUPROFEN, LEVOMILNACIPRAN, LISINOPRIL, MENTHOL (ROBITUSSIN), METHOCARBAMOL (ROBAXIN), NAPROXEN, NICOMOL (FATXAMINE), ONDANSETRON (ZOFRAN), OXYBUTYNIN, PARACETAMOL (ACETAMINOPHEN), PREDNISONE, SALBUTAMOL (ALBUTEROL), SALBUTAMOL SULFATE (PROAIR HFA), SULFAMETHOXAZOLE;TRIMETHOPRIM (BACTRIM) AND TRIAMCINOLONE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA / DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS : DEPRESSION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), ANXIETY ("MENTAL ANGUISH") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"), 1 MONTH 23 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"). ON (B)(6)2015, THE PATIENT EXPERIENCED HYPERCHOLESTEROLAEMIA ("HYPERCHOLESTEROLEMIA") AND RASH ("RASH"). ON (B)(6) 2015, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK AREA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER DISORDER OR URINARY TRACT PROBLEMS : URINARY INCONTINENCE"). ON (B)(6) 2016, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"). ON (B)(6) 2016, THE PATIENT EXPERIENCED HOT FLUSH ("HORMONAL CHANGES") AND MOOD SWINGS ("HORMONAL CHANGE: MOOD SWINGS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, HYPERSENSITIVITY ("ALLERGIC REACTION"), MENSTRUAL DISORDER ("MENSTRUAL BLEEDING"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), VISUAL IMPAIRMENT ("VISION DISORDER"), EYE DISORDER ("EYE PROBLEMS") AND HYPERTENSION ("HIGH BLOOD PRESSURE") AND WAS FOUND TO HAVE NEOPLASM MALIGNANT (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NEOPLASM ("TUMOR") AND TERATOMA ("TERATOMA"). THE PATIENT WAS TREATED WITH SURGERY ((SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, NEOPLASM MALIGNANT, HYPERSENSITIVITY, MENSTRUAL DISORDER, FEMALE SEXUAL DYSFUNCTION, URINARY INCONTINENCE, DYSMENORRHOEA, FATIGUE, GASTROINTESTINAL DISORDER, HOT FLUSH, URINARY TRACT INFECTION, MIGRAINE, HEADACHE, NAUSEA, DEPRESSION, NEOPLASM, TERATOMA, VISUAL IMPAIRMENT, EYE DISORDER, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA, MOOD SWINGS, ANXIETY, HYPERTENSION, HYPERCHOLESTEROLAEMIA, ABDOMINAL PAIN, RASH AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, EYE DISORDER, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, HYPERCHOLESTEROLAEMIA, HYPERSENSITIVITY, HYPERTENSION, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, NEOPLASM, NEOPLASM MALIGNANT, RASH, TERATOMA, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT: 188 LBS. PATIENT'S WEIGHT WAS GIVEN :188 LBS, 230 LBS. DISCREPANCY NOTED IN INSERTION DATE: UPDATED FROM (B)(6) 2011. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 43.5 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA URINARY TRACT INFECTION,HEADACHE. LOT NUMBER: 382191 IS NOT VALID LOT NUMBER: 882191 MANUFACTURING DATE:2011-07 EXPIRATION DATE:2014-07. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-JUL-2020: QUALITY SAFETY EVALUATION OF PTC. 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 NEOPLASM MALIGNANT ('CANCER') IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 382191(NOT VALID),882191(VAL)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST? NO". THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION, DEPRESSIVE DISORDER, INTERVERTEBRAL DISC BULGING, KIDNEY STONE, APPENDECTOMY, CHOLECYSTECTOMY AND ENDOMETRIAL ABLATION. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, DERMATITIS, BRONCHITIS, RASH, ABDOMINAL PAIN, FEELING UNWELL, VOMITING, MALAISE, LOSS OF CONSCIOUSNESS, DIZZINESS AGGRAVATED, CONFUSED, COUGH, ACUTE UPPER RESPIRATORY TRACT INFECTION, HYPERTENSION, SUICIDAL IDEATION, HEAD INJURY AND HYPERCHOLESTEREMIA. CONCOMITANT PRODUCTS INCLUDED CIPROFLOXACIN (CIPRO), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), IBUPROFEN, LEVOMILNACIPRAN, LISINOPRIL, MENTHOL (ROBITUSSIN), METHOCARBAMOL (ROBAXIN), NAPROXEN, NICOMOL (FATXAMINE), ONDANSETRON (ZOFRAN), OXYBUTYNIN, PARACETAMOL (ACETAMINOPHEN), PREDNISONE, SALBUTAMOL (ALBUTEROL), SALBUTAMOL SULFATE (PROAIR HFA), SULFAMETHOXAZOLE;TRIMETHOPRIM (BACTRIM) AND TRIAMCINOLONE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA / DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS : DEPRESSION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), ANXIETY ("MENTAL ANGUISH") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"), 1 MONTH 23 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED HYPERCHOLESTEROLAEMIA ("HYPERCHOLESTEROLEMIA") AND RASH ("RASH"). ON (B)(6) 2015, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK AREA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER DISORDER OR URINARY TRACT PROBLEMS : URINARY INCONTINENCE"). ON (B)(6) 2016, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"). ON (B)(6) 2016, THE PATIENT EXPERIENCED HOT FLUSH ("HORMONAL CHANGES") AND MOOD SWINGS ("HORMONAL CHANGE: MOOD SWINGS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, HYPERSENSITIVITY ("ALLERGIC REACTION"), MENSTRUAL DISORDER ("MENSTRUAL BLEEDING"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), VISUAL IMPAIRMENT ("VISION DISORDER"), EYE DISORDER ("EYE PROBLEMS") AND HYPERTENSION ("HIGH BLOOD PRESSURE") AND WAS FOUND TO HAVE NEOPLASM MALIGNANT (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NEOPLASM ("TUMOR") AND TERATOMA ("TERATOMA"). THE PATIENT WAS TREATED WITH SURGERY ((SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, NEOPLASM MALIGNANT, HYPERSENSITIVITY, MENSTRUAL DISORDER, FEMALE SEXUAL DYSFUNCTION, URINARY INCONTINENCE, DYSMENORRHOEA, FATIGUE, GASTROINTESTINAL DISORDER, HOT FLUSH, URINARY TRACT INFECTION, MIGRAINE, HEADACHE, NAUSEA, DEPRESSION, NEOPLASM, TERATOMA, VISUAL IMPAIRMENT, EYE DISORDER, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA, MOOD SWINGS, ANXIETY, HYPERTENSION, HYPERCHOLESTEROLAEMIA, ABDOMINAL PAIN, RASH AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, EYE DISORDER, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, HYPERCHOLESTEROLAEMIA, HYPERSENSITIVITY, HYPERTENSION, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, NEOPLASM, NEOPLASM MALIGNANT, RASH, TERATOMA, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT: 188 LBS PATIENT'S WEIGHT WAS GIVEN :188 LBS, 230 LBS DISCREPANCY NOTED IN INSERTION DATE: UPDATED FROM (B)(6) 2011 TO (B)(6) 2011. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 43.5 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA URINARY TRACT INFECTION,HEADACHE. LOT NUMBER: 382191 IS NOT VALID. LOT NUMBER: 882191 IS VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: PFS RECEIVED- REMOVAL DETAILS WERE ADDED. REPORTER INFORMATION WAS ADDED.SERIOUSNESS CRITERIA (MEDICALLY SIGNIFICANT) OF EVENT GENITAL HAEMORRHAGE WAS REMOVED. ON 20-MAR-2020: CONCOMITANT DRUG UPDATED ON 5-MAY-2020: ESSURE INSERTION DATE DISCREPANCY NOTED AND UPDATED TO MATCH RECENT INFORMATION, NO FURTHER NEW INFORMATION. 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 NEOPLASM MALIGNANT ('CANCER') IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 382191(NOT VALID),882191(VAL)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST? NO." THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION, DEPRESSIVE DISORDER, INTERVERTEBRAL DISC BULGING, KIDNEY STONE, APPENDECTOMY, CHOLECYSTECTOMY AND ENDOMETRIAL ABLATION. CONCURRENT CONDITIONS INCLUDED OBESITY, DERMATITIS, BRONCHITIS, RASH, ABDOMINAL PAIN, FEELING UNWELL, VOMITING, MALAISE, LOSS OF CONSCIOUSNESS, DIZZINESS AGGRAVATED, CONFUSED, COUGH, ACUTE UPPER RESPIRATORY TRACT INFECTION, HYPERTENSION, SUICIDAL IDEATION, HEAD INJURY AND HYPERCHOLESTEREMIA. CONCOMITANT PRODUCTS INCLUDED CIPROFLOXACIN (CIPRO), CODEINE PHOSPHATE;GUAIFENESIN;PHENIRAMINE MALEATE (ROBITUSSIN AC), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), IBUPROFEN, LEVOMILNACIPRAN, LISINOPRIL, METHOCARBAMOL (ROBAXIN), NAPROXEN, NICOMOL (FATXAMINE), ONDANSETRON (ZOFRAN), OXYBUTYNIN, PARACETAMOL (ACETAMINOPHEN), PREDNISONE, SALBUTAMOL (ALBUTEROL), SALBUTAMOL SULFATE (PROAIR HFA), SULFAMETHOXAZOLE;TRIMETHOPRIM (BACTRIM) AND TRIAMCINOLONE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA / DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS : DEPRESSION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), ANXIETY ("MENTAL ANGUISH") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"), 5 MONTHS 21 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED HYPERCHOLESTEROLAEMIA ("HYPERCHOLESTEROLEMIA") AND RASH ("RASH"). ON (B)(6) 2015, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK AREA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER DISORDER OR URINARY TRACT PROBLEMS : URINARY INCONTINENCE"). ON (B)(6) 2016, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"). ON (B)(6) 2016, THE PATIENT EXPERIENCED HOT FLUSH ("HORMONAL CHANGES") AND MOOD SWINGS ("HORMONAL CHANGE: MOOD SWINGS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, HYPERSENSITIVITY ("ALLERGIC REACTION"), MENSTRUAL DISORDER ("MENSTRUAL BLEEDING"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), VISUAL IMPAIRMENT ("VISION DISORDER"), EYE DISORDER ("EYE PROBLEMS") AND HYPERTENSION ("HIGH BLOOD PRESSURE") AND WAS FOUND TO HAVE NEOPLASM MALIGNANT (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NEOPLASM ("TUMOR") AND TERATOMA ("TERATOMA"). THE PATIENT WAS TREATED WITH SURGERY ((SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, NEOPLASM MALIGNANT, HYPERSENSITIVITY, MENSTRUAL DISORDER, FEMALE SEXUAL DYSFUNCTION, URINARY INCONTINENCE, DYSMENORRHOEA, FATIGUE, GASTROINTESTINAL DISORDER, HOT FLUSH, URINARY TRACT INFECTION, MIGRAINE, HEADACHE, NAUSEA, DEPRESSION, NEOPLASM, TERATOMA, VISUAL IMPAIRMENT, EYE DISORDER, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA, MOOD SWINGS, ANXIETY, HYPERTENSION, HYPERCHOLESTEROLAEMIA, ABDOMINAL PAIN, RASH AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, EYE DISORDER, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, HYPERCHOLESTEROLAEMIA, HYPERSENSITIVITY, HYPERTENSION, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, NEOPLASM, NEOPLASM MALIGNANT, RASH, TERATOMA, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT: 188 LBS. PATIENT'S WEIGHT WAS GIVEN :188 LBS, 230 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 43.5 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA URINARY TRACT INFECTION,HEADACHE. LOT NUMBER: 382191 IS NOT VALID. LOT NUMBER: 882191 IS VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PFS RECEIVED- REMOVAL DETAILS WERE ADDED. REPORTER INFORMATION WAS ADDED. SERIOUSNESS CRITERIA (MEDICALLY SIGNIFICANT) OF EVENT GENITAL HAEMORRHAGE WAS REMOVED. 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"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND NEOPLASM MALIGNANT ("CANCER") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 382191(INV), 882191(VAL)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST? NO". THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION, DEPRESSIVE DISORDER, INTERVERTEBRAL DISC BULGING, KIDNEY STONE, APPENDECTOMY, CHOLECYSTECTOMY AND ENDOMETRIAL ABLATION. CONCURRENT CONDITIONS INCLUDED OBESITY, DERMATITIS, BRONCHITIS, RASH, ABDOMINAL PAIN, FEELING UNWELL, VOMITING, MALAISE, LOSS OF CONSCIOUSNESS, DIZZINESS AGGRAVATED, CONFUSED, COUGH, ACUTE UPPER RESPIRATORY TRACT INFECTION, HYPERTENSION, SUICIDAL IDEATION, HEAD INJURY AND HYPERCHOLESTEREMIA. CONCOMITANT PRODUCTS INCLUDED CIPROFLOXACIN (CIPRO), CODEINE PHOS.W/GUAIFENESIN/PHENIRAMINE MAL. (ROBITUSSIN A C), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), IBUPROFEN, IBUPROFEN (MOTRIN), LEVOMILNACIPRAN, LISINOPRIL, METHOCARBAMOL (ROBAXIN), NAPROXEN, NICOMOL (FATXAMINE), ONDANSETRON (ZOFRAN), OXYBUTYNIN, PARACETAMOL (ACETAMINOPHEN), PREDNISONE, SALBUTAMOL (ALBUTEROL), SALBUTAMOL SULFATE (PROAIR HFA), SULFAMETHOXAZOLE;TRIMETHOPRIM (BACTRIM) AND TRIAMCINOLONE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA/DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS : DEPRESSION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), ANXIETY ("MENTAL ANGUISH") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"), 5 MONTHS 21 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / WEIGHT GAIN/LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2015, THE PATIENT EXPERIENCED HYPERCHOLESTEROLAEMIA ("HYPERCHOLESTEROLEMIA") AND RASH ("RASH"). ON (B)(6) 2015, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER DISORDER OR URINARY TRACT PROBLEMS : URINARY INCONTINENCE"). ON (B)(6) 2016, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"). ON (B)(6) 2016, THE PATIENT EXPERIENCED HOT FLUSH ("HORMONAL CHANGES") AND MOOD SWINGS ("HORMONAL CHANGE: MOOD SWINGS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN, HYPERSENSITIVITY ("ALLERGIC REACTION"), MENSTRUAL DISORDER ("MENSTRUAL BLEEDING"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), VISUAL IMPAIRMENT ("VISION DISORDER"), EYE DISORDER ("EYE PROBLEMS"), HYPERTENSION ("HIGH BLOOD PRESSURE") AND BACK PAIN ("LOWER BACK AREA") AND WAS FOUND TO HAVE NEOPLASM MALIGNANT (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NEOPLASM ("TUMOR") AND TERATOMA ("TERATOMA"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, NEOPLASM MALIGNANT, HYPERSENSITIVITY, MENSTRUAL DISORDER, FEMALE SEXUAL DYSFUNCTION, URINARY INCONTINENCE, DYSMENORRHOEA, FATIGUE, GASTROINTESTINAL DISORDER, HOT FLUSH, URINARY TRACT INFECTION, MIGRAINE, HEADACHE, NAUSEA, DEPRESSION, NEOPLASM, TERATOMA, VISUAL IMPAIRMENT, EYE DISORDER, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA, MOOD SWINGS, ANXIETY, HYPERTENSION, HYPERCHOLESTEROLAEMIA, ABDOMINAL PAIN, RASH AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, EYE DISORDER, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, HYPERCHOLESTEROLAEMIA, HYPERSENSITIVITY, HYPERTENSION, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, NEOPLASM, NEOPLASM MALIGNANT, RASH, TERATOMA, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: CURRENT WEIGHT: (B)(6). PATIENT'S WEIGHT WAS GIVEN: (B)(6). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 38.4 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA URINARY TRACT INFECTION,HEADACHE. LOT NUMBER: 382191 IS INVALID. LOT NUMBER: 882191 IS VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-NOV-2018: PFS RECEIVED. CONCOMITANT MEDICATION AND CONDITION ADDED. EVENT BACK PAIN WERE ADDED. INCIDENT: WE RECEIVED A LOT NUMBER/RETURNED SAMPLE 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 |
|---|---|---|---|---|---|---|---|
| 976816 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 382191(NOT VALID), 882191 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN (PARACETAMOL)| ALBUTEROL (SALBUTAMOL)| ALBUTEROL [SALBUTAMOL]| ALBUTEROL [SALBUTAMOL]| ALBUTEROL [SALBUTAMOL]| ALLEGRA| ALLEGRA| ALLEGRA| ALLEGRA (FEXOFENADINE HYDROCHLORIDE)| BACTRIM| BACTRIM| BACTRIM| BACTRIM (SULFAMETHOXAZOLE,TRIMETHOPRIM)| CIPRO (CIPROFLOXACIN)| CIPRO [CIPROFLOXACIN]| CIPRO [CIPROFLOXACIN]| CIPRO [CIPROFLOXACIN]| FATXAMINE| FATXAMINE| FATXAMINE| FATXAMINE (NICOMOL)| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN (IBUPROFEN)| LEVOMILNACIPRAN| LEVOMILNACIPRAN| LEVOMILNACIPRAN| LEVOMILNACIPRAN (LEVOMILNACIPRAN)| LISINOPRIL| LISINOPRIL| LISINOPRIL| LISINOPRIL (LISINOPRIL)| MOTRIN (IBUPROFEN [IBUPROFEN])| NAPROXEN| NAPROXEN| NAPROXEN| NAPROXEN| NAPROXEN| NAPROXEN| NAPROXEN (NAPROXEN)| NAPROXEN (NAPROXEN)| NORCO| NORCO| NORCO| NORCO (HYDROCODONE BITARTRATE,PARACETAMOL)| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| OXYBUTYNIN| OXYBUTYNIN| OXYBUTYNIN| OXYBUTYNIN (OXYBUTYNIN)| PREDNISONE| PREDNISONE| PREDNISONE| PREDNISONE| PROAIR HFA| PROAIR HFA| PROAIR HFA| PROAIR HFA (SALBUTAMOL SULFATE)| ROBAXIN| ROBAXIN| ROBAXIN| ROBAXIN (METHOCARBAMOL)| ROBITUSSIN A C| ROBITUSSIN [MENTHOL]| ROBITUSSIN [MENTHOL]| ROBITUSSIN [MENTHOL]| TRIAMCINOLONE| TRIAMCINOLONE| TRIAMCINOLONE| TRIAMCINOLONE| ZOFRAN (ONDANSETRON)| ZOFRAN [ONDANSETRON]| ZOFRAN [ONDANSETRON]| ZOFRAN [ONDANSETRON]| ACETAMINOPHEN (PARACETAMOL)| ALBUTEROL (SALBUTAMOL)| ALLEGRA (FEXOFENADINE HYDROCHLORIDE)| BACTRIM (SULFAMETHOXAZOLE,TRIMETHOPRIM)| CIPRO (CIPROFLOXACIN)| FATXAMINE (NICOMOL)| IBUPROFEN (IBUPROFEN)| LEVOMILNACIPRAN (LEVOMILNACIPRAN)| LISINOPRIL (LISINOPRIL)| MOTRIN (IBUPROFEN [IBUPROFEN])| NAPROXEN (NAPROXEN)| NAPROXEN (NAPROXEN)| NORCO (HYDROCODONE BITARTRATE,PARACETAMOL)| OXYBUTYNIN (OXYBUTYNIN)| PREDNISONE| PROAIR HFA (SALBUTAMOL SULFATE)| ROBAXIN (METHOCARBAMOL)| ROBITUSSIN A C| TRIAMCINOLONE| ZOFRAN (ONDANSETRON) |