ESSURE
Report
- Report Number
- 2951250-2017-05964
- Event Type
- Injury
- Date Received
- November 13, 2017
- Date of Event
- January 1, 2011
- Report Date
- November 8, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("RIGHT ESSURE COIL HAD PERFORATED HER FALLOPIAN TUBE."), UTERINE PERFORATION ("PERFORATION :UTERUS"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE THE RIGHT ESSURE COIL WAS IN THE ENDOMETRIAL CAVITY EXTENDING T THE CORNEA"), GENITAL HAEMORRHAGE ("ABNORMAL HEAVY BLEEDING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENOMETRORRHAGIA ("MENORRHAGIA/ABNORMAL BLEEDING (MENORRHAGIA), IRREGULAR PERIODS WITH HEAVY CLOTS") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. R-910511; L-871973) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2 ((B)(6) 2004, (B)(6) 2011) AND MISCARRIAGE (1 PREGNANCY TERMINATION). IN 2011, THE PATIENT EXPERIENCED MENOMETRORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL INFECTION ("VAGINAL AND BLADDER INFECTIONS/INFECTION - BLADDER, VAGINITIS, YEAST"), CYSTITIS ("VAGINAL AND BLADDER INFECTIONS/INFECTION - BLADDER, VAGINITIS"), FUNGAL INFECTION ("VAGINAL AND BLADDER INFECTIONS/INFECTION - BLADDER, VAGINITIS, YEAST"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA/APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("DISCHARGE/VAGINAL DISCHARGE"), ABDOMINAL PAIN LOWER ("CRAMPING"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND BACK PAIN ("BACK PAIN/LOWER BACK PAIN"). IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL ODOUR ("VAGINAL ODOUR") AND MENORRHAGIA ("MENORRHAGIA/ABNORMAL BLEEDING (MENORRHAGIA), IRREGULAR PERIODS WITH HEAVY CLOTS"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) PAINFUL INTERCOURSE WITH BLOOD"). IN 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE/FATIGUE"), ANXIETY ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY, DEPRESSION, MODD SWINGS"), DEPRESSION ("DEPRESSION/ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY, DEPRESSION, MOOD SWINGS") AND MOOD SWINGS ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY, DEPRESSION, MOOD SWINGS"). IN 2013, THE PATIENT EXPERIENCED WHITE BLOOD CELL COUNT INCREASED ("BLOOD OR HEART DISORDER/CONDITION - SLIGHTLY ELEVATED WHITE BLOOD CELL COUNT"). IN (B)(6) 2014, THE PATIENT EXPERIENCED TOOTH LOSS ("DENTAL PROBLEMS LOST TOOTH"). IN (B)(6) 2015, THE PATIENT EXPERIENCED WEIGHT DECREASED ("WEIGHT GAIN OR LOSS SPECIFY WHICH PAIN: WEIGHT LOSS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALLERGY TO METALS ("ALLERGIC OR HYPERSENSITIVITY REACTION - METALS/NICKEL ALLERGY"). IN 2015, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS/HAIR LOSS"), BREAST PAIN ("HORMONAL CHANGES - SORE BREASTS AFTER REMOVAL OF ESSURE") AND ENDOMETRIOSIS ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION: ENDOMETRIOSIS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PAIN/PAIN/SEVERE PAIN"), DISTURBANCE IN ATTENTION ("TROUBLE CONCENTRATING"), PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"), PAIN OF SKIN ("RASHES OR SKIN CONDITIONS - SENSITIVE SKINS") AND NEURALGIA ("NERVE PAIN IN LEGS"). THE PATIENT WAS TREATED WITH COLONAPAN, SURGERY (HYSTERECTOMY WITH(BILATERAL SALPINGECTOMY, BILATERAL SALPINGECTOMY,ROBOTIC, ASSISTANCE)), SURGERY (HYSTERECTOMY WITH(BILATERAL SALPINGECTOMY, BILATERAL SALPINGECTOMY,ROBOTIC, ASSISTANCE)), SURGERY (HYSTERECTOMY WITH(BILATERAL SALPINGECTOMY, BILATERAL SALPINGECTOMY,ROBOTIC, ASSISTANCE)), SURGERY (ON OR ABOUT (B)(6) 2012, UNDERWENT A NOVASURE ABLATION TREAT CONSTANT BLEEDING), SURGERY (NOVASURE ABLATION), SURGERY (NOVASURE ABLATION) AND ALTERNATIVE THERAPY (PULLED TOOTH AND BRIDGE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, DEVICE EXPULSION, GENITAL HAEMORRHAGE, CYSTITIS, FUNGAL INFECTION, DISTURBANCE IN ATTENTION, PROCEDURAL PAIN, ABDOMINAL PAIN LOWER AND MENORRHAGIA OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE, MENOMETRORRHAGIA, PELVIC PAIN, VAGINAL INFECTION, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, FATIGUE, ALOPECIA, ANXIETY, DEPRESSION, MOOD SWINGS, VAGINAL DISCHARGE, ALLERGY TO METALS, WHITE BLOOD CELL COUNT INCREASED, TOOTH LOSS, DYSMENORRHOEA, BREAST PAIN, PAIN OF SKIN, WEIGHT DECREASED, VAGINAL ODOUR, ENDOMETRIOSIS, BACK PAIN AND NEURALGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ANXIETY, BACK PAIN, BREAST PAIN, CYSTITIS, DEPRESSION, DEVICE EXPULSION, DISTURBANCE IN ATTENTION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FUNGAL INFECTION, GENITAL HAEMORRHAGE, MENOMETRORRHAGIA, MENORRHAGIA, MOOD SWINGS, NEURALGIA, PAIN OF SKIN, PELVIC PAIN, PROCEDURAL PAIN, TOOTH LOSS, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VAGINAL ODOUR, WEIGHT DECREASED AND WHITE BLOOD CELL COUNT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES. ULTRASOUND SCAN - ON (B)(6) 2015: RIGHT ESSURE COIL HAD PERFORATED FALLOPIAN TUBE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PARTIAL DEVICE EXPULSION, MOOD SWINGS, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-JUN-2018: PLAINTIFF FACT SHEET RECEIVED. EVENTS PERFORATION: UTERUS WAS ADDED. PREVIOUSLY REPORTED EVENT IRREGULAR PERIODS WITH HEAVY CLOTS CODED SEPARATELY. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("RIGHT ESSURE COIL HAD PERFORATED HER FALLOPIAN TUBE."), UTERINE PERFORATION ("PERFORATION :UTERUS"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE THE RIGHT ESSURE COIL WAS IN THE ENDOMETRIAL CAVITY EXTENDING T THE CORNEA/MIGRATED/EMBEDD"), GENITAL HAEMORRHAGE ("ABNORMAL HEAVY BLEEDING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENOMETRORRHAGIA ("MENORRHAGIA/ABNORMAL BLEEDING (MENORRHAGIA), IRREGULAR PERIODS WITH HEAVY CLOTS") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. R-910511; L-871973) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2 ((B)(6) 2004, (B)(6) 2011), MISCARRIAGE (1 PREGNANCY TERMINATION) AND PAP SMEAR ABNORMAL IN 2007. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA. CONCURRENT CONDITIONS INCLUDED VAGINAL CANDIDA, TONSILLOLITH, VAGINAL CANDIDA, URINARY TRACT INFECTION, DYSFUNCTIONAL UTERINE BLEEDING, MENOMETRORRHAGIA AND TASTE METALLIC. CONCOMITANT PRODUCTS INCLUDED LORAZEPAM (ATIVAN). IN 2011, THE PATIENT EXPERIENCED MENOMETRORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL INFECTION ("VAGINAL AND BLADDER INFECTIONS/INFECTION - BLADDER, VAGINITIS, YEAST"), CYSTITIS ("VAGINAL AND BLADDER INFECTIONS/INFECTION - BLADDER, VAGINITIS"), FUNGAL INFECTION ("VAGINAL AND BLADDER INFECTIONS/INFECTION - BLADDER, VAGINITIS, YEAST"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA/APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("DISCHARGE/VAGINAL DISCHARGE"), ABDOMINAL PAIN LOWER ("CRAMPING"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND BACK PAIN ("BACK PAIN/LOWER BACK PAIN"). IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL ODOUR ("VAGINAL ODOUR") AND MENORRHAGIA ("MENORRHAGIA/ABNORMAL BLEEDING (MENORRHAGIA), IRREGULAR PERIODS WITH HEAVY CLOTS"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) PAINFUL INTERCOURSE WITH BLOOD"). IN 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE/FATIGUE"), ANXIETY ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY, DEPRESSION, MODD SWINGS"), DEPRESSION ("DEPRESSION/ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY, DEPRESSION, MOOD SWINGS") AND MOOD SWINGS ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY, DEPRESSION, MOOD SWINGS"). IN 2013, THE PATIENT EXPERIENCED WHITE BLOOD CELL COUNT INCREASED ("BLOOD OR HEART DISORDER/CONDITION - SLIGHTLY ELEVATED WHITE BLOOD CELL COUNT"). IN (B)(6) 2014, THE PATIENT EXPERIENCED TOOTH LOSS ("DENTAL PROBLEMS LOST TOOTH"). IN (B)(6) 2015, THE PATIENT EXPERIENCED WEIGHT DECREASED ("WEIGHT GAIN OR LOSS SPECIFY WHICH PAIN: WEIGHT LOSS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALLERGY TO METALS ("ALLERGIC OR HYPERSENSITIVITY REACTION - METALS/NICKEL ALLERGY"). IN 2015, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS/HAIR LOSS"), BREAST PAIN ("HORMONAL CHANGES - SORE BREASTS AFTER REMOVAL OF ESSURE/BREAST HURTS") AND ENDOMETRIOSIS ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION: ENDOMETRIOSIS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PAIN/PAIN/SEVERE PAIN"), DISTURBANCE IN ATTENTION ("TROUBLE CONCENTRATING"), PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"), SENSITIVE SKIN ("RASHES OR SKIN CONDITIONS - SENSITIVE SKINS"), NEURALGIA ("NERVE PAIN IN LEGS"), FEAR ("IM SCARED"), INSOMNIA ("INSOMNIA"), NIGHT SWEATS ("NIGHT SWEAT"), MUSCULOSKELETAL DISCOMFORT ("NECK DISCOMFORT/SHOULDER DISCOMFORT"), GASTROINTESTINAL PAIN ("PAINFUL BOWEL"), URINARY TRACT INFECTION ("UTI") AND BREAST TENDERNESS ("BREAST TENDERNESS"). THE PATIENT WAS TREATED WITH COLONAPAN, SURGERY (HYSTERECTOMY WITH(BILATERAL SALPINGECTOMY, BILATERAL SALPINGECTOMY, ROBOTIC, ASSISTANCE)), SURGERY (NOVASURE ABLATION), ALTERNATIVE THERAPY (PULLED TOOTH AND BRIDGE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, DEVICE EXPULSION, GENITAL HAEMORRHAGE, CYSTITIS, FUNGAL INFECTION, DISTURBANCE IN ATTENTION, PROCEDURAL PAIN, ABDOMINAL PAIN LOWER, MENORRHAGIA, FEAR, INSOMNIA, NIGHT SWEATS, MUSCULOSKELETAL DISCOMFORT, GASTROINTESTINAL PAIN, URINARY TRACT INFECTION AND BREAST TENDERNESS OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE, MENOMETRORRHAGIA, PELVIC PAIN, VAGINAL INFECTION, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, FATIGUE, ALOPECIA, ANXIETY, DEPRESSION, MOOD SWINGS, VAGINAL DISCHARGE, ALLERGY TO METALS, WHITE BLOOD CELL COUNT INCREASED, TOOTH LOSS, DYSMENORRHOEA, BREAST PAIN, SENSITIVE SKIN, WEIGHT DECREASED, VAGINAL ODOUR, ENDOMETRIOSIS, BACK PAIN AND NEURALGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ANXIETY, BACK PAIN, BREAST PAIN, BREAST TENDERNESS, CYSTITIS, DEPRESSION, DEVICE EXPULSION, DISTURBANCE IN ATTENTION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FALLOPIAN TUBE PERFORATION, FATIGUE, FEAR, FEMALE SEXUAL DYSFUNCTION, FUNGAL INFECTION, GASTROINTESTINAL PAIN, GENITAL HAEMORRHAGE, INSOMNIA, MENOMETRORRHAGIA, MENORRHAGIA, MOOD SWINGS, MUSCULOSKELETAL DISCOMFORT, NEURALGIA, NIGHT SWEATS, PELVIC PAIN, PROCEDURAL PAIN, SENSITIVE SKIN, TOOTH LOSS, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VAGINAL ODOUR, WEIGHT DECREASED AND WHITE BLOOD CELL COUNT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: DATE OF IMPLANT : (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES ULTRASOUND SCAN - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION; ON (B)(6) 2015: RIGHT ESSURE COIL HAD PERFORATED FALLOPIAN TUBE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PARTIAL DEVICE EXPULSION, MOOD SWINGS, PELVIC PAIN, VAGINAL YEAST INFECTION, DYSMENORRHEA. LOW BACK PAIN LOT NUMBER: 871973 MANUFACTURE DATE: 2011-06 EXPIRATION DATE: 2014-06. LOT NUMBER 910511: MANUFACTURE 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 29-OCT-2018: PFS , SOCIAL MEDIA AND MR RECEIVED. REPORTERS INFORMATION UPDATED. CASE MEDICALLY CONFIRMED. PLAINTIFF DEMOGRAPHY ADDED. EVENTS: SCARED, INSOMNIA, MUSCULOSKELETAL DISCOMFORT, GASTROINTESTINAL PAIN, UTI, BREAST TENDERNESS WERE ADDED. CONCOMITANT CONDITION, CONCOMITANT DRUGS WERE ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("RIGHT ESSURE COIL HAD PERFORATED HER FALLOPIAN TUBE."), UTERINE PERFORATION ("PERFORATION :UTERUS"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE THE RIGHT ESSURE COIL WAS IN THE ENDOMETRIAL CAVITY EXTENDING T THE CORNEA"), GENITAL HAEMORRHAGE ("ABNORMAL HEAVY BLEEDING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENOMETRORRHAGIA ("MENORRHAGIA/ABNORMAL BLEEDING (MENORRHAGIA), IRREGULAR PERIODS WITH HEAVY CLOTS") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. R-910511; L-871973) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2 ((B)(6) 2004, (B)(6) 2011) AND MISCARRIAGE (1 PREGNANCY TERMINATION). IN 2011, THE PATIENT EXPERIENCED MENOMETRORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL INFECTION ("VAGINAL AND BLADDER INFECTIONS/INFECTION - BLADDER, VAGINITIS, YEAST"), CYSTITIS ("VAGINAL AND BLADDER INFECTIONS/INFECTION - BLADDER, VAGINITIS"), FUNGAL INFECTION ("VAGINAL AND BLADDER INFECTIONS/INFECTION - BLADDER, VAGINITIS, YEAST"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA/APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("DISCHARGE/VAGINAL DISCHARGE"), ABDOMINAL PAIN LOWER ("CRAMPING"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND BACK PAIN ("BACK PAIN/LOWER BACK PAIN"). IN NOVEMBER 2011, THE PATIENT HAD ESSURE INSERTED. IN NOVEMBER 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL ODOUR ("VAGINAL ODOUR") AND MENORRHAGIA ("MENORRHAGIA/ABNORMAL BLEEDING (MENORRHAGIA), IRREGULAR PERIODS WITH HEAVY CLOTS"). IN DECEMBER 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) PAINFUL INTERCOURSE WITH BLOOD"). IN 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE/FATIGUE"), ANXIETY ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY, DEPRESSION, MODD SWINGS"), DEPRESSION ("DEPRESSION/ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY, DEPRESSION, MOOD SWINGS") AND MOOD SWINGS ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY, DEPRESSION, MOOD SWINGS"). IN 2013, THE PATIENT EXPERIENCED WHITE BLOOD CELL COUNT INCREASED ("BLOOD OR HEART DISORDER/CONDITION - SLIGHTLY ELEVATED WHITE BLOOD CELL COUNT"). IN JANUARY 2014, THE PATIENT EXPERIENCED TOOTH LOSS ("DENTAL PROBLEMS LOST TOOTH"). IN JANUARY 2015, THE PATIENT EXPERIENCED WEIGHT DECREASED ("WEIGHT GAIN OR LOSS SPECIFY WHICH PAIN: WEIGHT LOSS"). IN MAY 2015, THE PATIENT EXPERIENCED ALLERGY TO METALS ("ALLERGIC OR HYPERSENSITIVITY REACTION - METALS/NICKEL ALLERGY"). IN 2015, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS/HAIR LOSS"), BREAST PAIN ("HORMONAL CHANGES - SORE BREASTS AFTER REMOVAL OF ESSURE") AND ENDOMETRIOSIS ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION: ENDOMETRIOSIS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PAIN/PAIN/SEVERE PAIN"), DISTURBANCE IN ATTENTION ("TROUBLE CONCENTRATING"), PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"), PAIN OF SKIN ("RASHES OR SKIN CONDITIONS - SENSITIVE SKINS") AND NEURALGIA ("NERVE PAIN IN LEGS"). THE PATIENT WAS TREATED WITH COLONAPAN, SURGERY (HYSTERECTOMY WITH(BILATERAL SALPINGECTOMY, BILATERAL SALPINGECTOMY,ROBOTIC, ASSISTANCE)), SURGERY (HYSTERECTOMY WITH(BILATERAL SALPINGECTOMY, BILATERAL SALPINGECTOMY,ROBOTIC, ASSISTANCE)), SURGERY (HYSTERECTOMY WITH(BILATERAL SALPINGECTOMY, BILATERAL SALPINGECTOMY,ROBOTIC, ASSISTANCE)), SURGERY (ON OR ABOUT APR-2012, UNDERWENT A NOVASURE ABLATION TREAT CONSTANT BLEEDING), SURGERY (NOVASURE ABLATION), SURGERY (NOVASURE ABLATION) AND ALTERNATIVE THERAPY (PULLED TOOTH AND BRIDGE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, DEVICE EXPULSION, GENITAL HAEMORRHAGE, CYSTITIS, FUNGAL INFECTION, DISTURBANCE IN ATTENTION, PROCEDURAL PAIN, ABDOMINAL PAIN LOWER AND MENORRHAGIA OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE, MENOMETRORRHAGIA, PELVIC PAIN, VAGINAL INFECTION, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, FATIGUE, ALOPECIA, ANXIETY, DEPRESSION, MOOD SWINGS, VAGINAL DISCHARGE, ALLERGY TO METALS, WHITE BLOOD CELL COUNT INCREASED, TOOTH LOSS, DYSMENORRHOEA, BREAST PAIN, PAIN OF SKIN, WEIGHT DECREASED, VAGINAL ODOUR, ENDOMETRIOSIS, BACK PAIN AND NEURALGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ANXIETY, BACK PAIN, BREAST PAIN, CYSTITIS, DEPRESSION, DEVICE EXPULSION, DISTURBANCE IN ATTENTION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FUNGAL INFECTION, GENITAL HAEMORRHAGE, MENOMETRORRHAGIA, MENORRHAGIA, MOOD SWINGS, NEURALGIA, PAIN OF SKIN, PELVIC PAIN, PROCEDURAL PAIN, TOOTH LOSS, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VAGINAL ODOUR, WEIGHT DECREASED AND WHITE BLOOD CELL COUNT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN FEBRUARY 2012: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES ULTRASOUND SCAN - ON 25-APR-2015: RIGHT ESSURE COIL HAD PERFORATED FALLOPIAN TUBE CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PARTIAL DEVICE EXPULSION, MOOD SWINGS, PELVIC PAIN. LOT NUMBER: 871973 MANUFACTURE DATE: 2011-06 EXPIRATION DATE: 2014-06 . LOT NUMBER 910511: MANUFACTURE 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 14-AUG-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("RIGHT ESSURE COIL HAD PERFORATED HER FALLOPIAN TUBE."), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE THE RIGHT ESSURE COIL WAS IN THE ENDOMETRIAL CAVITY EXTENDING T THE CORNEA"), GENITAL HAEMORRHAGE ("ABNORMAL HEAVY BLEEDING"), MENOMETRORRHAGIA ("MENORRHAGIA/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), IRREGULAR PERIODS WITH HEAVY CLOTS") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO: R-910511; L-871973) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA, PARITY 2 ON (B)(6) 2004, ON (B)(6) 2011) AND MISCARRIAGE (1 PREGNANCY TERMINATION). IN 2011, THE PATIENT EXPERIENCED MENOMETRORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VULVOVAGINAL MYCOTIC INFECTION ("VAGINAL AND BLADDER INFECTIONS/INFECTION - BLADDER, VAGINITIS, YEAST"), CYSTITIS ("VAGINAL AND BLADDER INFECTIONS/INFECTION - BLADDER, VAGINITIS"), UROGENITAL INFECTION FUNGAL ("VAGINAL AND BLADDER INFECTIONS/INFECTION - BLADDER, VAGINITIS, YEAST"), DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) PAINFUL INTERCOURSE WITH BLOOD"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA/APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("DISCHARGE/VAGINAL DISCHARGE"), ABDOMINAL PAIN LOWER ("CRAMPING"), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND BACK PAIN ("BACK PAIN/LOWER BACK PAIN"). IN NOVEMBER 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE/FATIGUE"), ANXIETY ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY, DEPRESSION, MODD SWINGS"), DEPRESSION ("DEPRESSION/ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY, DEPRESSION, MOOD SWINGS") AND MOOD SWINGS ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: ANXIETY, DEPRESSION, MOOD SWINGS"). IN 2013, THE PATIENT EXPERIENCED WHITE BLOOD CELL COUNT INCREASED ("BLOOD OR HEART DISORDER/CONDITION - SLIGHTLY ELEVATED WHITE BLOOD CELL COUNT"). IN 2014, THE PATIENT EXPERIENCED TOOTH LOSS ("DENTAL PROBLEMS LOST TOOTH"). IN 2015, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS/HAIR LOSS"), ALLERGY TO METALS ("ALLERGIC OR HYPERSENSITIVITY REACTION - METALS/NICKEL ALLERGY"), BREAST PAIN ("HORMONAL CHANGES - SORE BREASTS AFTER REMOVAL OF ESSURE"), WEIGHT DECREASED ("WEIGHT GAIN OR LOSS SPECIFY WHICH PAIN: WEIGHT LOSS") AND ENDOMETRIOSIS ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION: ENDOMETRIOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PAIN/PAIN/SEVERE PAIN"), DISTURBANCE IN ATTENTION ("TROUBLE CONCENTRATING"), PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"), PAIN OF SKIN ("RASHES OR SKIN CONDITIONS - SENSITIVE SKINS"), VAGINAL ODOUR ("VAGINAL ODOUR") AND NEURALGIA ("NERVE PAIN IN LEGS"). THE PATIENT WAS TREATED WITH COLONAPAN, SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY TO REMOVE ESSURE), SURGERY (ON OR ABOUT APR-2012, UNDERWENT A NOVASURE ABLATION TREAT CONSTANT BLEEDING), SURGERY (NOVASURE ABLATION), AND ALTERNATIVE THERAPY (PULLED TOOTH AND BRIDGE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, GENITAL HAEMORRHAGE, CYSTITIS, UROGENITAL INFECTION FUNGAL, DISTURBANCE IN ATTENTION, PROCEDURAL PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE MENOMETRORRHAGIA, PELVIC PAIN, VULVOVAGINAL MYCOTIC INFECTION, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, FATIGUE, ALOPECIA, ANXIETY, DEPRESSION, MOOD SWINGS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, ALLERGY TO METALS, WHITE BLOOD CELL COUNT INCREASED, TOOTH LOSS, DYSMENORRHOEA, BREAST PAIN, PAIN OF SKIN, WEIGHT DECREASED, VAGINAL ODOUR, ENDOMETRIOSIS, BACK PAIN AND NEURALGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ANXIETY, BACK PAIN, BREAST PAIN, CYSTITIS, DEPRESSION, DEVICE EXPULSION, DISTURBANCE IN ATTENTION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, MENOMETRORRHAGIA, MOOD SWINGS, NEURALGIA, PAIN OF SKIN, PELVIC PAIN, PROCEDURAL PAIN, TOOTH LOSS, UROGENITAL INFECTION FUNGAL, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL ODOUR, VULVOVAGINAL MYCOTIC INFECTION, WEIGHT DECREASED AND WHITE BLOOD CELL COUNT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN FEBRUARY 2012: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES ULTRASOUND SCAN - ON (B)(6) 2015: RIGHT ESSURE COIL HAD PERFORATED FALLOPIAN TUBE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PARTIAL DEVICE EXPULSION, MOOD SWINGS, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. EVENTS PER PFS: ABNORMAL BLEEDING (VAGINAL), ALLERGIC OR HYPERSENSITIVITY REACTION - METALS, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), BLOOD OR HEART DISORDER/CONDITION - SLIGHTLY ELEVATED WHITE BLOOD CELL COUNT, DENTAL PROBLEMS, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, HAIR LOSS, HORMONAL CHANGES - SORE BREASTS AFTER REMOVAL OF ESSURE, HYSTERECTOMY (FULL), INFECTION - BLADDER, VAGINITIS, YEAST, MIGRATION OF ESSURE DEVICE THE RIGHT ESSURE COIL WAS IN THE ENDOMETRIAL CAVITY, NICKEL ALLERGY, PAIN, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - MOOD SWINGS, RASHES OR SKIN CONDITIONS - SENSITIVE SKINS, ALLERGIC REACTIONS, VAGINAL DISCHARGE, WEIGHT LOSS, NERVE PAIN, ENDOMETRIOSIS WERE ADDED. PATIENT'S MEDICAL HISTORY WAS ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("RIGHT ESSURE COIL HAD PERFORATED HER FALLOPIAN TUBE.") AND GENITAL HAEMORRHAGE ("ABNORMAL HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("MENORRHAGIA"), PELVIC PAIN ("SEVERE PAIN"), VAGINAL INFECTION ("VAGINAL AND BLADDER INFECTIONS"), CYSTITIS ("VAGINAL AND BLADDER INFECTIONS"), DYSPAREUNIA ("DYSPAREUNIA"), SEXUAL DYSFUNCTION ("APAREUNIA"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), ANXIETY ("ANXIETY"), DEPRESSION ("DEPRESSION"), DISTURBANCE IN ATTENTION ("TROUBLE CONCENTRATING"), PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"), VAGINAL DISCHARGE ("DISCHARGE"), ABDOMINAL PAIN LOWER ("CRAMPING") AND PAIN ("SEVERE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2015, UNDERWENT A HYSTERECTOMY AND BILATERAL SALPINGECTOMY TO REMOVE ESSURE) AND SURGERY (ON OR ABOUT (B)(6), UNDERWENT A NOVASURE ABLATION TREAT CONSTANT BLEEDING). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, VAGINAL INFECTION, CYSTITIS, DYSPAREUNIA, SEXUAL DYSFUNCTION, FATIGUE, ALOPECIA, ANXIETY, DEPRESSION, DISTURBANCE IN ATTENTION, PROCEDURAL PAIN, VAGINAL DISCHARGE, ABDOMINAL PAIN LOWER AND PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, CYSTITIS, DEPRESSION, DISTURBANCE IN ATTENTION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PAIN, PELVIC PAIN, PROCEDURAL PAIN, SEXUAL DYSFUNCTION, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM IN (B)(6) 2012: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES ULTRASOUND SCAN ON (B)(6) 2015: RIGHT ESSURE COIL HAD PERFORATED FALLOPIAN TUBE NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 803447 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | R-910511; L-871973 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R | ATIVAN |