ESSURE
Report
- Report Number
- 2951250-2019-02201
- Event Type
- Injury
- Date Received
- May 27, 2019
- Date of Event
- January 1, 2011
- Report Date
- October 18, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('ABDOMINAL PAIN'), EXOSTOSIS ('SHOULDER SPURR') AND MALIGNANT MELANOMA ('TUMOR / TERATOMA / CANCER TYPE: MELANOMA & ATYPICAL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863566) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ASTHMA, ARTHRITIS, ANEMIA AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED DIENOGEST;ESTRADIOL VALERATE (NATAZIA), ETHINYLESTRADIOL;NORETHISTERONE ACETATE (LOESTRIN), MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PIROXICAM (PAXIL). IN 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), EYE ALLERGY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: EYES"), EAR DISORDER ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: EAR"), URINARY TRACT INFECTION ("INFECTION (BLADDER URINARY TRACT/VAGINAL) TYPE: UTI") AND DYSMENORRHOEA ("DYSMENORRHEA"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT WAS FOUND TO HAVE MALIGNANT MELANOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED ECZEMA ("ECZEMA RASHES OR SKIN CONDITIONS TYPE: ECZEMA"), MOLLUSCUM CONTAGIOSUM ("RASHES OR SKIN CONDITIONS TYPE: MOLLUSCUM"), KERATOSIS PILARIS ("RASHES OR SKIN CONDITIONS TYPE: KERATOSIS PILARIS"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), TREMOR ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: SHAKING"), NERVOUS SYSTEM DISORDER ("NERVE JUMPS") AND VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED FIBROMYALGIA ("FIBROMYALGIA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("INFECTION (BLADDER URINARY TRACT/VAGINAL) TYPE:BACTERIAL VAGINOSIS"). IN 2014, THE PATIENT EXPERIENCED BORDERLINE PERSONALITY DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: (BPD) BORDERLINE PERSONALITY DISORDER"). IN (B)(6) 2015, THE PATIENT EXPERIENCED NEPHROLITHIASIS ("INFECTION (BLADDER URINARY TRACT/VAGINAL) TYPE: KIDNEY STONE,"). IN 2016, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EXOSTOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLADDER DISORDER ("BLADDER DISORDER"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), INFLAMMATORY BOWEL DISEASE ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: INFLAMMATORY BOWEL DISEASE"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("JOINT PAIN/HIP PAIN"), MYALGIA ("MUSCLE PAIN") AND PAIN IN EXTREMITY ("HANDS PAIN"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF BONE SPUR AND TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, URINARY TRACT DISORDER, VAGINAL DISCHARGE, INFLAMMATORY BOWEL DISEASE, BACK PAIN, ARTHRALGIA, MYALGIA AND PAIN IN EXTREMITY WAS RESOLVING, THE EXOSTOSIS, MALIGNANT MELANOMA, ECZEMA, VAGINAL HAEMORRHAGE, MENORRHAGIA, EYE ALLERGY, EAR DISORDER, NEPHROLITHIASIS, URINARY TRACT INFECTION, BACTERIAL VAGINOSIS, BORDERLINE PERSONALITY DISORDER, MOLLUSCUM CONTAGIOSUM, KERATOSIS PILARIS, BLADDER DISORDER, MIGRAINE, HEADACHE, NAUSEA, TREMOR, NERVOUS SYSTEM DISORDER, VISION BLURRED, FATIGUE, WEIGHT INCREASED AND FIBROMYALGIA OUTCOME WAS UNKNOWN AND THE DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, BACTERIAL VAGINOSIS, BLADDER DISORDER, BORDERLINE PERSONALITY DISORDER, DYSMENORRHOEA, DYSPAREUNIA, EAR DISORDER, ECZEMA, EXOSTOSIS, EYE ALLERGY, FATIGUE, FIBROMYALGIA, HEADACHE, INFLAMMATORY BOWEL DISEASE, KERATOSIS PILARIS, MALIGNANT MELANOMA, MENORRHAGIA, MIGRAINE, MOLLUSCUM CONTAGIOSUM, MYALGIA, NAUSEA, NEPHROLITHIASIS, NERVOUS SYSTEM DISORDER, PAIN IN EXTREMITY, TREMOR, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: (B)(6) 2011 (AS PER PFS); (B)(6) 2011 (AS PER MR). THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 3. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-MAY-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('ABDOMINAL PAIN'), NEPHROLITHIASIS ('INFECTION (BLADDER URINARY TRACT/VAGINAL) TYPE: KIDNEY STONE,'), EXOSTOSIS ('SHOULDER SPURR') AND MALIGNANT MELANOMA ('TUMOR / TERATOMA / CANCER TYPE: MELANOMA & ATYPICAL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863566) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ASTHMA, ARTHRITIS, ANEMIA AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED DIENOGEST;ESTRADIOL VALERATE (NATAZIA), ETHINYLESTRADIOL;NORETHISTERONE ACETATE (LOESTRIN), MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PIROXICAM (PAXIL). IN 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), EYE ALLERGY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: EYES"), EAR DISORDER ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: EAR") AND DYSMENORRHOEA ("DYSMENORRHEA"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER URINARY TRACT/VAGINAL) TYPE: UTI"). IN 2012, THE PATIENT WAS FOUND TO HAVE MALIGNANT MELANOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED ECZEMA ("ECZEMARASHES OR SKIN CONDITIONS TYPE: ECZEMA"), MOLLUSCUM CONTAGIOSUM ("RASHES OR SKIN CONDITIONS TYPE: MOLLUSEUM"), KERATOSIS PILARIS ("RASHES OR SKIN CONDITIONS TYPE: KERATOSIS PILARIS"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), TREMOR ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: SHAKING"), NERVOUS SYSTEM DISORDER ("NERVE JUMPS") AND VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED FIBROMYALGIA ("FIBROMYALGIA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("INFECTION (BLADDER URINARY TRACT/VAGINAL) TYPE:BACTERIAL VAGINOSIS"). IN 2014, THE PATIENT EXPERIENCED BORDERLINE PERSONALITY DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: (BPD) BORDERLINE PERSONALITY DISORDER"). IN (B)(6) 2015, THE PATIENT EXPERIENCED NEPHROLITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2016, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EXOSTOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLADDER DISORDER ("BLADDER DISORDER"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,/ URINARY PROBLEM"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), INFLAMMATORY BOWEL DISEASE ("GASTROINTESTINAL OR DIGESTIVE SYSTE CONDITION TYPE: INFLAMMATORY BOWEL DISEASE"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("JOINT PAIN/HIP PAIN"), MYALGIA ("MUSCLE PAIN"), PAIN IN EXTREMITY ("HANDS PAIN") AND GASTROINTESTINAL DISORDER ("GASTROINTESTINAL PROBLEM"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF BONE SPUR, TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED) AND SURGERY: KIDNEY STONE). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, BACK PAIN AND PAIN IN EXTREMITY HAD RESOLVED, THE NEPHROLITHIASIS, EXOSTOSIS, MALIGNANT MELANOMA, ECZEMA, VAGINAL HAEMORRHAGE, MENORRHAGIA, EYE ALLERGY, EAR DISORDER, URINARY TRACT INFECTION, BACTERIAL VAGINOSIS, BORDERLINE PERSONALITY DISORDER, MOLLUSCUM CONTAGIOSUM, KERATOSIS PILARIS, BLADDER DISORDER, MIGRAINE, HEADACHE, NAUSEA, TREMOR, NERVOUS SYSTEM DISORDER, VISION BLURRED, FATIGUE, WEIGHT INCREASED AND FIBROMYALGIA OUTCOME WAS UNKNOWN AND THE URINARY TRACT DISORDER, VAGINAL DISCHARGE, INFLAMMATORY BOWEL DISEASE, ARTHRALGIA, MYALGIA AND GASTROINTESTINAL DISORDER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, BACTERIAL VAGINOSIS, BLADDER DISORDER, BORDERLINE PERSONALITY DISORDER, DYSMENORRHOEA, DYSPAREUNIA, EAR DISORDER, ECZEMA, EXOSTOSIS, EYE ALLERGY, FATIGUE, FIBROMYALGIA, GASTROINTESTINAL DISORDER, HEADACHE, INFLAMMATORY BOWEL DISEASE, KERATOSIS PILARIS, MALIGNANT MELANOMA, MENORRHAGIA, MIGRAINE, MOLLUSCUM CONTAGIOSUM, MYALGIA, NAUSEA, NEPHROLITHIASIS, NERVOUS SYSTEM DISORDER, PAIN IN EXTREMITY, TREMOR, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED:(B)(6) 2011 (AS PER PFS) (B)(6) 2011(AS PER MR). THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 3. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED. EVENT ; GASTROINTESTINAL PROBLEM WERE ADDED. EVENTS ; ABDOMINAL PAIN, BACK PAIN, HANDS PAIN OUTCOME 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('ABDOMINAL PAIN'), EXOSTOSIS ('SHOULDER SPURR') AND MALIGNANT MELANOMA ('TUMOR / TERATOMA / CANCER TYPE: MELANOMA & ATYPICAL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863566) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ASTHMA, ARTHRITIS, ANEMIA AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED DIENOGEST;ESTRADIOL VALERATE (NATAZIA), ETHINYLESTRADIOL;NORETHISTERONE ACETATE (LOESTRIN), MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PIROXICAM (PAXIL). IN 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), EYE ALLERGY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: EYES"), EAR DISORDER ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: EAR"), URINARY TRACT INFECTION ("INFECTION (BLADDER URINARY TRACT/VAGINAL) TYPE: UTI") AND DYSMENORRHOEA ("DYSMENORRHEA"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT WAS FOUND TO HAVE MALIGNANT MELANOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED ECZEMA ("ECZEMARASHES OR SKIN CONDITIONS TYPE: ECZEMA"), MOLLUSCUM CONTAGIOSUM ("RASHES OR SKIN CONDITIONS TYPE: MOLLUSEUM"), KERATOSIS PILARIS ("RASHES OR SKIN CONDITIONS TYPE: KERATOSIS PILARIS"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), TREMOR ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: SHAKING"), NERVOUS SYSTEM DISORDER ("NERVE JUMPS") AND VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED FIBROMYALGIA ("FIBROMYALGIA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("INFECTION (BLADDER URINARY TRACT/VAGINAL) TYPE:BACTERIAL VAGINOSIS"). IN 2014, THE PATIENT EXPERIENCED BORDERLINE PERSONALITY DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: (BPD) BORDERLINE PERSONALITY DISORDER"). IN (B)(6) 2015, THE PATIENT EXPERIENCED NEPHROLITHIASIS ("INFECTION (BLADDER URINARY TRACT/VAGINAL) TYPE: KIDNEY STONE,"). IN 2016, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EXOSTOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLADDER DISORDER ("BLADDER DISORDER"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), INFLAMMATORY BOWEL DISEASE ("GASTROINTESTINAL OR DIGESTIVE SYSTE CONDITION TYPE: INFLAMMATORY BOWEL DISEASE"), BACK PAIN ("BACK PAIN"), ARTHRALGIA ("JOINT PAIN/HIP PAIN"), MYALGIA ("MUSCLE PAIN") AND PAIN IN EXTREMITY ("HANDS PAIN"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF BONE SPUR AND TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, URINARY TRACT DISORDER, VAGINAL DISCHARGE, INFLAMMATORY BOWEL DISEASE, BACK PAIN, ARTHRALGIA, MYALGIA AND PAIN IN EXTREMITY WAS RESOLVING, THE EXOSTOSIS, MALIGNANT MELANOMA, ECZEMA, VAGINAL HAEMORRHAGE, MENORRHAGIA, EYE ALLERGY, EAR DISORDER, NEPHROLITHIASIS, URINARY TRACT INFECTION, BACTERIAL VAGINOSIS, BORDERLINE PERSONALITY DISORDER, MOLLUSCUM CONTAGIOSUM, KERATOSIS PILARIS, BLADDER DISORDER, MIGRAINE, HEADACHE, NAUSEA, TREMOR, NERVOUS SYSTEM DISORDER, VISION BLURRED, FATIGUE, WEIGHT INCREASED AND FIBROMYALGIA OUTCOME WAS UNKNOWN AND THE DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, BACTERIAL VAGINOSIS, BLADDER DISORDER, BORDERLINE PERSONALITY DISORDER, DYSMENORRHOEA, DYSPAREUNIA, EAR DISORDER, ECZEMA, EXOSTOSIS, EYE ALLERGY, FATIGUE, FIBROMYALGIA, HEADACHE, INFLAMMATORY BOWEL DISEASE, KERATOSIS PILARIS, MALIGNANT MELANOMA, MENORRHAGIA, MIGRAINE, MOLLUSCUM CONTAGIOSUM, MYALGIA, NAUSEA, NEPHROLITHIASIS, NERVOUS SYSTEM DISORDER, PAIN IN EXTREMITY, TREMOR, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: (B)(6) 2011 (AS PER PFS); (B)(6) 2011 (AS PER MR). THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 3. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-MAY-2019: PFS RECEIVED. REPORTERS INFORMATION UPDATED. LOT NO. ADDED. EVENT :INJURY NOS WERE UPDATED TO VAGINAL HEMORRHAGE .NEW EVENTS:ENORRHAGIA), ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: EYES ANDEARS, INFECTION (BLADDER URINARY TRACT/VAGINAL) TYPE: KIDNEY STONE, UTI, BACTERIAL VAGINOSIS, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: (BPD) BORDERLINE PERSONALITY DISORDER, RASHES OR SKIN CONDITIONS TYPE: ECZEMA, MOLLUSEUM,KERATOSIS PILARIS, BLADDER OR URINARY PROBLEMS OR CHANGES, MIGRAINES / HEADACHES, NAUSEA, NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: SHAKING, NERVE JUMPS, DYSMENORRHEA (CRAMPING), SURGERY (OTHER) TYPE OF SURGERY: REMOVAL OF BONE SPURON RIGHT SHOULDER, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), TUMOR / TERATOMA / CANCER TYPE: MELANOMA & ATYPICAL, PAIN,VAGINAL DISCHARGE, VISION/EYE PROBLEMS TYPE: BLURRY, FATIGUE, WEIGHT GAIN, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: INFLAMMATORY BOWEL DISEASE, OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: FIBROMYALGIA WERE ADDED. MEDICAL HISTORY , CONCOMITANT DRUG , LAB DATA WERE ADDED. 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-CONFORMANCE'S 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 |
|---|---|---|---|---|---|---|---|
| 436811 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863566 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R | DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| LOESTRIN| LOESTRIN| LOESTRIN| NATAZIA| NATAZIA| NATAZIA| PAXIL [PIROXICAM]| PAXIL [PIROXICAM]| PAXIL [PIROXICAM] |