ESSURE
Report
- Report Number
- 2951250-2017-04720
- Event Type
- Injury
- Date Received
- October 16, 2017
- Report Date
- March 30, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ("THE COILS WERE DEEPLY EMBEDDED IN THE FALLOPIAN TUBE TISSUE, AT THE JUNCTION WITH THE UTERUS"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING"), SALPINGITIS ("SALPINGITIS") AND INFLAMMATION ("INFLAMMATION,") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 954893) 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)1991,(B)(6)1996) AND MISCARRIAGE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED JOINT SWELLING, OVERACTIVE BLADDER AND FIBROSIS. ON (B)(6)2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6)2011, THE PATIENT EXPERIENCED FATIGUE ("CHRONIC FATIGUE"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/PROLONGED MENSTRUATION/ABNORMAL MESTRUATION"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), FUNGAL INFECTION ("YEAST INFECTION"), TOOTH DISORDER ("DENTAL PROBLEMS") AND ALLERGY TO METALS ("NICKEL ALLERGY") WITH RASH. ON (B)(6)2016, THE PATIENT EXPERIENCED INFLAMMATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"), BACK PAIN ("SEVERE LOWER BACK PAIN / LOWER BACK PAIN"), ARTHRALGIA ("HIP PAIN/ SEVERE JOINT PAIN/ KNEE PAIN"), VAGINAL INFECTION ("CHRONIC VAGINAL INFECTIONS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), SKIN IRRITATION ("SKIN IRRITATION"), ERYTHEMA ("REDNESS"), SKIN DISORDER ("SKIN BUMPS"), DRY SKIN ("DRYNESS OF SKIN"), SKIN DISCOLOURATION ("PATCHES RESEMBLING BURN MARKS AND BLISTERS"), DENTAL CARIES ("TOOTH DECAY"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY TRACT PROBLEM") AND PAIN ("WAIST PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6)2016,TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY /BILATERAL SALPINGECTOMY - TOTAL LAPAROS), SURGERY (ON (B)(6)2016,TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY /BILATERAL SALPINGECTOMY - TOTAL LAPAROS), SURGERY (ON (B)(6)2016,TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY /BILATERAL SALPINGECTOMY - TOTAL LAPAROS) AND SURGERY (APPENDECTOMY). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, ABDOMINAL PAIN LOWER, SALPINGITIS, INFLAMMATION, DYSMENORRHOEA, ABDOMINAL DISTENSION, VAGINAL INFECTION, VAGINAL DISCHARGE, SKIN IRRITATION, ERYTHEMA, SKIN DISORDER, DRY SKIN, SKIN DISCOLOURATION, FATIGUE, WEIGHT INCREASED, MENORRHAGIA, DENTAL CARIES, VAGINAL HAEMORRHAGE, FUNGAL INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, ALLERGY TO METALS AND PAIN OUTCOME WAS UNKNOWN AND THE BACK PAIN AND ARTHRALGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, DENTAL CARIES, DRY SKIN, DYSMENORRHOEA, EMBEDDED DEVICE, ERYTHEMA, FATIGUE, FUNGAL INFECTION, INFLAMMATION, MENORRHAGIA, PAIN, SALPINGITIS, SKIN DISCOLOURATION, SKIN DISORDER, SKIN IRRITATION, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. PATIENT TOLERATED THE INSERTION PROCEDURE WELL. THE COIL IS DEEPLY EMBEDDED IN THE TISSUE, MAKING REMOVAL QUITE DIFFICULT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2016: CONFIRMING FULL OCCLUSION FALLOPIAN TUBE ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: PELVC PAIN, SALPINGITIS, EMBEDDED DEVICE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: MEDICAL RECORD RECEIVED. EVENTS EMBEDDED DEVICE AND SALPINGITIS ARE ADDED. CONCOMITANT CONDITION ARE ADDED. PRODUCT , PATIENT & REPORTER INFORMATION UPDATED. 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 EMBEDDED DEVICE ("THE COILS WERE DEEPLY EMBEDDED IN THE FALLOPIAN TUBE TISSUE, AT THE JUNCTION WITH THE UTERUS"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING"), SALPINGITIS ("SALPINGITIS") AND INFLAMMATION ("INFLAMMATION,") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 954893) 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) 1991, (B)(6) 1996) AND MISCARRIAGE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED JOINT SWELLING, OVERACTIVE BLADDER, FIBROSIS AND ACUTE APPENDICITIS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN") AND URINARY INCONTINENCE ("URINARY INCONTINENCE"). ON (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("CHRONIC FATIGUE"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/PROLONGED MENSTRUATION/ABNORMAL "MENSTRUATION""), DENTAL CARIES ("TOOTH DECAY"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), FUNGAL INFECTION ("YEAST INFECTION"), TOOTH DISORDER ("DENTAL PROBLEMS") AND ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("ABDOMINAL BLOATING") AND VAGINAL INFECTION ("CHRONIC VAGINAL INFECTIONS") WITH VAGINAL DISCHARGE. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN/DYSMENORRHEA (CRAMPING)"), SKIN IRRITATION ("SKIN IRRITATION") WITH RASH, ERYTHEMA ("REDNESS"), SKIN DISORDER ("SKIN BUMPS"), DRY SKIN ("DRYNESS OF SKIN"), SKIN DISCOLOURATION ("PATCHES RESEMBLING BURN MARKS"), ANXIETY ("EMOTIONAL ANGUISH") AND BLISTER ("BLISTERS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED INFLAMMATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("SEVERE LOWER BACK PAIN / LOWER BACK PAIN/PHYSICAL PAIN"), SWELLING ("BODY SWELLING") AND JOINT SWELLING ("JOINT SWELLING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHRALGIA ("HIP PAIN/ SEVERE JOINT PAIN/ KNEE PAIN"), PAIN ("WAIST PAIN"), ADENOMYOSIS ("ENDOMETRIOSIS OF UTERUS") AND CERVICITIS ("INFLAMMATORY DISEASE OF CERVIX UTERI"). THE PATIENT WAS TREATED WITH IBUPROFEN (MOTRIN), IBUPROFEN, SURGERY (ON (B)(6) 2016,TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY /BILATERAL SALPINGECTOMY - TOTAL LAPAROS), AND SURGERY (APPENDECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, ABDOMINAL PAIN LOWER, SALPINGITIS, INFLAMMATION, DYSMENORRHOEA, ABDOMINAL DISTENSION, VAGINAL INFECTION, SKIN IRRITATION, ERYTHEMA, SKIN DISORDER, DRY SKIN, SKIN DISCOLOURATION, FATIGUE, WEIGHT INCREASED, MENORRHAGIA, DENTAL CARIES, VAGINAL HAEMORRHAGE, FUNGAL INFECTION, TOOTH DISORDER, ALLERGY TO METALS, PAIN, ANXIETY, BLISTER, ADENOMYOSIS, CERVICITIS, SWELLING, JOINT SWELLING AND URINARY INCONTINENCE OUTCOME WAS UNKNOWN AND THE BACK PAIN AND ARTHRALGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ALLERGY TO METALS, ANXIETY, ARTHRALGIA, BACK PAIN, BLISTER, CERVICITIS, DENTAL CARIES, DRY SKIN, DYSMENORRHOEA, EMBEDDED DEVICE, ERYTHEMA, FATIGUE, FUNGAL INFECTION, INFLAMMATION, JOINT SWELLING, MENORRHAGIA, PAIN, SALPINGITIS, SKIN DISCOLOURATION, SKIN DISORDER, SKIN IRRITATION, SWELLING, TOOTH DISORDER, URINARY INCONTINENCE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. PATIENT TOLERATED THE INSERTION PROCEDURE WELL. THE COIL IS DEEPLY EMBEDDED IN THE TISSUE, MAKING REMOVAL QUITE DIFFICULT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: CONFIRMING FULL OCCLUSION FALLOPIAN TUBE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: "PELVIC" PAIN, SALPINGITIS, EMBEDDED DEVICE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-JUN-2018: PFS RECEIVED- NEW EVENT EMOTIONAL ANGUISH, BLISTERS, ENDOMETRIOSIS OF UTERUS, INFLAMMATORY DISEASE OF CERVIX UTERI, JOINT SWELLING, SWELLING ADDED. BLADDER OR URINARY PROBLEMS OR CHANGES UPDATED TO URINARY INCONTINENCE. NEW REPORTER, TREATMENT MEDICATION, CONCOMITANT CONDITION 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 EMBEDDED DEVICE ("THE COILS WERE DEEPLY EMBEDDED IN THE FALLOPIAN TUBE TISSUE, AT THE JUNCTION WITH THE UTERUS"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING"), FALLOPIAN TUBE CANCER ("OVARIES AND UTERINE CANCER STARTS IN THE FALLOPIAN TUBES"), SALPINGITIS ("SALPINGITIS") AND INFLAMMATION ("INFLAMMATION,") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 954893-INVALID) 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) 1991), ((B)(6) 1996), MISCARRIAGE AND APPENDECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED JOINT SWELLING, OVERACTIVE BLADDER, FIBROSIS, ACUTE APPENDICITIS AND OBESITY. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN") AND URINARY INCONTINENCE ("URINARY INCONTINENCE"). ON (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("CHRONIC FATIGUE"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/PROLONGED MENSTRUATION/ABNORMAL MENSTRUATION"), DENTAL CARIES ("TOOTH DECAY"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), FUNGAL INFECTION ("YEAST INFECTION"), TOOTH DISORDER ("DENTAL PROBLEMS") AND ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("ABDOMINAL BLOATING") AND VAGINAL INFECTION ("CHRONIC VAGINAL INFECTIONS") WITH VAGINAL DISCHARGE. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN/DYSMENORRHEA (CRAMPING)"), SKIN IRRITATION ("SKIN IRRITATION") WITH RASH, ERYTHEMA ("REDNESS"), SKIN DISORDER ("SKIN BUMPS"), DRY SKIN ("DRYNESS OF SKIN"), SKIN DISCOLOURATION ("PATCHES RESEMBLING BURN MARKS"), ANXIETY ("EMOTIONAL ANGUISH") AND BLISTER ("BLISTERS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED INFLAMMATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("SEVERE LOWER BACK PAIN / LOWER BACK PAIN/PHYSICAL PAIN"), SWELLING ("BODY SWELLING") AND JOINT SWELLING ("JOINT SWELLING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE CANCER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHRALGIA ("HIP PAIN/ SEVERE JOINT PAIN/ KNEE PAIN"), PAIN ("WAIST PAIN"), ADENOMYOSIS ("ENDOMETRIOSIS OF UTERUS") AND CERVICITIS ("INFLAMMATORY DISEASE OF CERVIX UTERI"). THE PATIENT WAS TREATED WITH IBUPROFEN (MOTRIN), IBUPROFEN, SURGERY (ON (B)(6) 2016,TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY /BILATERAL SALPINGECTOMY - TOTAL LAPAROS) AND SURGERY (APPENDECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, ABDOMINAL PAIN LOWER, FALLOPIAN TUBE CANCER, SALPINGITIS, DYSMENORRHOEA, ABDOMINAL DISTENSION, VAGINAL INFECTION, SKIN IRRITATION, ERYTHEMA, SKIN DISORDER, DRY SKIN, SKIN DISCOLOURATION, FATIGUE, WEIGHT INCREASED, MENORRHAGIA, DENTAL CARIES, VAGINAL HAEMORRHAGE, FUNGAL INFECTION, TOOTH DISORDER, ALLERGY TO METALS, PAIN, ANXIETY, BLISTER, ADENOMYOSIS, CERVICITIS, SWELLING AND JOINT SWELLING OUTCOME WAS UNKNOWN AND THE INFLAMMATION, BACK PAIN, ARTHRALGIA AND URINARY INCONTINENCE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ALLERGY TO METALS, ANXIETY, ARTHRALGIA, BACK PAIN, BLISTER, CERVICITIS, DENTAL CARIES, DRY SKIN, DYSMENORRHOEA, EMBEDDED DEVICE, ERYTHEMA, FALLOPIAN TUBE CANCER, FATIGUE, FUNGAL INFECTION, INFLAMMATION, JOINT SWELLING, MENORRHAGIA, PAIN, SALPINGITIS, SKIN DISCOLOURATION, SKIN DISORDER, SKIN IRRITATION, SWELLING, TOOTH DISORDER, URINARY INCONTINENCE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. PATIENT TOLERATED THE INSERTION PROCEDURE WELL. THE COIL IS DEEPLY EMBEDDED IN THE TISSUE, MAKING REMOVAL QUITE DIFFICULT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: CONFIRMING FULL OCCLUSION FALLOPIAN TUBE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: PELVC PAIN, SALPINGITIS, EMBEDDED DEVICE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-OCT-2018: SOCIAL MEDIA RECEIVED:EVENT FALLOPIAN TUBE CANCER ADDED AND REPORTERS ADDED. INCIDENT: NO VALID 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ("THE COILS WERE DEEPLY EMBEDDED IN THE FALLOPIAN TUBE TISSUE, AT THE JUNCTION WITH THE UTERUS"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING"), SALPINGITIS ("SALPINGITIS") AND INFLAMMATION ("INFLAMMATION,") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 954893-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2 (27DEC1991,05JUN1996), MISCARRIAGE AND APPENDECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED JOINT SWELLING, OVERACTIVE BLADDER, FIBROSIS, ACUTE APPENDICITIS AND OBESITY. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN") AND URINARY INCONTINENCE ("URINARY INCONTINENCE"). ON (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("CHRONIC FATIGUE"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/PROLONGED MENSTRUATION/ABNORMAL MESTRUATION"), DENTAL CARIES ("TOOTH DECAY"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), FUNGAL INFECTION ("YEAST INFECTION"), TOOTH DISORDER ("DENTAL PROBLEMS") AND ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("ABDOMINAL BLOATING") AND VAGINAL INFECTION ("CHRONIC VAGINAL INFECTIONS") WITH VAGINAL DISCHARGE. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN/DYSMENORRHEA (CRAMPING)"), SKIN IRRITATION ("SKIN IRRITATION") WITH RASH, ERYTHEMA ("REDNESS"), SKIN DISORDER ("SKIN BUMPS"), DRY SKIN ("DRYNESS OF SKIN"), SKIN DISCOLOURATION ("PATCHES RESEMBLING BURN MARKS"), ANXIETY ("EMOTIONAL ANGUISH") AND BLISTER ("BLISTERS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED INFLAMMATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("SEVERE LOWER BACK PAIN / LOWER BACK PAIN/PHYSICAL PAIN"), SWELLING ("BODY SWELLING") AND JOINT SWELLING ("JOINT SWELLING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHRALGIA ("HIP PAIN/ SEVERE JOINT PAIN/ KNEE PAIN"), PAIN ("WAIST PAIN"), ADENOMYOSIS ("ENDOMETRIOSIS OF UTERUS") AND CERVICITIS ("INFLAMMATORY DISEASE OF CERVIX UTERI"). THE PATIENT WAS TREATED WITH IBUPROFEN (MOTRIN), IBUPROFEN, SURGERY (ON (B)(6) 2016,TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY /BILATERAL SALPINGECTOMY - TOTAL LAPAROS) AND SURGERY (APPENDECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, ABDOMINAL PAIN LOWER, SALPINGITIS, DYSMENORRHOEA, ABDOMINAL DISTENSION, VAGINAL INFECTION, SKIN IRRITATION, ERYTHEMA, SKIN DISORDER, DRY SKIN, SKIN DISCOLOURATION, FATIGUE, WEIGHT INCREASED, MENORRHAGIA, DENTAL CARIES, VAGINAL HAEMORRHAGE, FUNGAL INFECTION, TOOTH DISORDER, ALLERGY TO METALS, PAIN, ANXIETY, BLISTER, ADENOMYOSIS, CERVICITIS, SWELLING AND JOINT SWELLING OUTCOME WAS UNKNOWN AND THE INFLAMMATION, BACK PAIN, ARTHRALGIA AND URINARY INCONTINENCE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ALLERGY TO METALS, ANXIETY, ARTHRALGIA, BACK PAIN, BLISTER, CERVICITIS, DENTAL CARIES, DRY SKIN, DYSMENORRHOEA, EMBEDDED DEVICE, ERYTHEMA, FATIGUE, FUNGAL INFECTION, INFLAMMATION, JOINT SWELLING, MENORRHAGIA, PAIN, SALPINGITIS, SKIN DISCOLOURATION, SKIN DISORDER, SKIN IRRITATION, SWELLING, TOOTH DISORDER, URINARY INCONTINENCE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. PATIENT TOLERATED THE INSERTION PROCEDURE WELL. THE COIL IS DEEPLY EMBEDDED IN THE TISSUE, MAKING REMOVAL QUITE DIFFICULT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.7 KG/SQM. HYSTEROSALPINGOGRAM - ON 16-AUG-2014: CONFIRMING FULL OCCLUSION FALLOPIAN TUBE ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: PELVC PAIN, SALPINGITIS, EMBEDDED DEVICE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-OCT-2018: PLAINTIFF FACT SHEET RECEIVED. EVENT OUTCOME WAS UPDATED FOR THE EVENT: URINARY INCONTINENCE AND INFLAMMATION. CONCOMITANT AND HISTORICAL CONDITION WAS ADDED. INCIDENT NO VALID 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ("THE COILS WERE DEEPLY EMBEDDED IN THE FALLOPIAN TUBE TISSUE, AT THE JUNCTION WITH THE UTERUS"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING"), SALPINGITIS ("SALPINGITIS") AND INFLAMMATION ("INFLAMMATION,") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 954893-INVALID) 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) 1991, (B)(6) 1996) AND MISCARRIAGE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED JOINT SWELLING, OVERACTIVE BLADDER, FIBROSIS AND ACUTE APPENDICITIS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN") AND URINARY INCONTINENCE ("URINARY INCONTINENCE"). ON(B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("CHRONIC FATIGUE"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/PROLONGED MENSTRUATION/ABNORMAL MENSTRUATION"), DENTAL CARIES ("TOOTH DECAY"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), FUNGAL INFECTION ("YEAST INFECTION"), TOOTH DISORDER ("DENTAL PROBLEMS") AND ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("ABDOMINAL BLOATING") AND VAGINAL INFECTION ("CHRONIC VAGINAL INFECTIONS") WITH VAGINAL DISCHARGE. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN/DYSMENORRHEA (CRAMPING)"), SKIN IRRITATION ("SKIN IRRITATION") WITH RASH, ERYTHEMA ("REDNESS"), SKIN DISORDER ("SKIN BUMPS"), DRY SKIN ("DRYNESS OF SKIN"), SKIN DISCOLOURATION ("PATCHES RESEMBLING BURN MARKS"), ANXIETY ("EMOTIONAL ANGUISH") AND BLISTER ("BLISTERS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED INFLAMMATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("SEVERE LOWER BACK PAIN / LOWER BACK PAIN/PHYSICAL PAIN"), SWELLING ("BODY SWELLING") AND JOINT SWELLING ("JOINT SWELLING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHRALGIA ("HIP PAIN/ SEVERE JOINT PAIN/ KNEE PAIN"), PAIN ("WAIST PAIN"), ADENOMYOSIS ("ENDOMETRIOSIS OF UTERUS") AND CERVICITIS ("INFLAMMATORY DISEASE OF CERVIX UTERI"). THE PATIENT WAS TREATED WITH IBUPROFEN (MOTRIN), IBUPROFEN, SURGERY (ON (B)(6) 2016,TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY /BILATERAL SALPINGECTOMY - TOTAL LAPAROS), SURGERY (ON (B)(6) 2016,TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY /BILATERAL SALPINGECTOMY - TOTAL LAPAROS), SURGERY (ON (B)(6) 2016,TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY /BILATERAL SALPINGECTOMY - TOTAL LAPAROS) AND SURGERY (APPENDECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, ABDOMINAL PAIN LOWER, SALPINGITIS, INFLAMMATION, DYSMENORRHOEA, ABDOMINAL DISTENSION, VAGINAL INFECTION, SKIN IRRITATION, ERYTHEMA, SKIN DISORDER, DRY SKIN, SKIN DISCOLOURATION, FATIGUE, WEIGHT INCREASED, MENORRHAGIA, DENTAL CARIES, VAGINAL HAEMORRHAGE, FUNGAL INFECTION, TOOTH DISORDER, ALLERGY TO METALS, PAIN, ANXIETY, BLISTER, ADENOMYOSIS, CERVICITIS, SWELLING, JOINT SWELLING AND URINARY INCONTINENCE OUTCOME WAS UNKNOWN AND THE BACK PAIN AND ARTHRALGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ALLERGY TO METALS, ANXIETY, ARTHRALGIA, BACK PAIN, BLISTER, CERVICITIS, DENTAL CARIES, DRY SKIN, DYSMENORRHOEA, EMBEDDED DEVICE, ERYTHEMA, FATIGUE, FUNGAL INFECTION, INFLAMMATION, JOINT SWELLING, MENORRHAGIA, PAIN, SALPINGITIS, SKIN DISCOLOURATION, SKIN DISORDER, SKIN IRRITATION, SWELLING, TOOTH DISORDER, URINARY INCONTINENCE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. PATIENT TOLERATED THE INSERTION PROCEDURE WELL. THE COIL IS DEEPLY EMBEDDED IN THE TISSUE, MAKING REMOVAL QUITE DIFFICULT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: CONFIRMING FULL OCCLUSION FALLOPIAN TUBE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: PELVC PAIN, SALPINGITIS, EMBEDDED DEVICE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-JUL-2018: UPDATE OF INFORMATION (BATCH NOT VALID). INCIDENT: 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('THE COILS WERE DEEPLY EMBEDDED IN THE FALLOPIAN TUBE TISSUE, AT THE JUNCTION WITH THE UTERUS'), ABDOMINAL PAIN LOWER ('SEVERE ABDOMINAL CRAMPING'), SALPINGITIS ('SALPINGITIS') AND INFLAMMATION ('INFLAMMATION,') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 954893-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2 ((B)(6) 1991, (B)(6) 996), MISCARRIAGE AND APPENDECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED JOINT SWELLING, OVERACTIVE BLADDER, FIBROSIS, ACUTE APPENDICITIS AND OBESITY. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED URINARY INCONTINENCE ("URINARY INCONTINENCE"). ON (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("CHRONIC FATIGUE"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/PROLONGED MENSTRUATION/ABNORMAL MESTRUATION"), DENTAL CARIES ("TOOTH DECAY"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), FUNGAL INFECTION ("YEAST INFECTION"), TOOTH DISORDER ("DENTAL PROBLEMS") AND ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("ABDOMINAL BLOATING") AND VAGINAL INFECTION ("CHRONIC VAGINAL INFECTIONS") WITH VAGINAL DISCHARGE. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN/DYSMENORRHEA (CRAMPING)"), SKIN IRRITATION ("SKIN IRRITATION") WITH RASH, ERYTHEMA ("REDNESS"), SKIN DISORDER ("SKIN BUMPS"), DRY SKIN ("DRYNESS OF SKIN"), SKIN DISCOLOURATION ("PATCHES RESEMBLING BURN MARKS"), ANXIETY ("EMOTIONAL ANGUISH") AND BLISTER ("BLISTERS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED INFLAMMATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("SEVERE LOWER BACK PAIN / LOWER BACK PAIN/PHYSICAL PAIN"), SWELLING ("BODY SWELLING") AND JOINT SWELLING ("JOINT SWELLING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHRALGIA ("HIP PAIN/ SEVERE JOINT PAIN/ KNEE PAIN"), PAIN ("WAIST PAIN"), ADENOMYOSIS ("ENDOMETRIOSIS OF UTERUS") AND CERVICITIS ("INFLAMMATORY DISEASE OF CERVIX UTERI"). THE PATIENT WAS TREATED WITH IBUPROFEN, AND SURGERY (ON (B)(6) 2016,TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY /BILATERAL SALPINGECTOMY - TOTAL LAPAROS AND APPENDECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, ABDOMINAL PAIN LOWER, SALPINGITIS, DYSMENORRHOEA, ABDOMINAL DISTENSION, VAGINAL INFECTION, SKIN IRRITATION, ERYTHEMA, SKIN DISORDER, DRY SKIN, SKIN DISCOLOURATION, FATIGUE, WEIGHT INCREASED, MENORRHAGIA, DENTAL CARIES, VAGINAL HAEMORRHAGE, FUNGAL INFECTION, TOOTH DISORDER, ALLERGY TO METALS, PAIN, ANXIETY, BLISTER, ADENOMYOSIS, CERVICITIS, SWELLING AND JOINT SWELLING OUTCOME WAS UNKNOWN AND THE INFLAMMATION, BACK PAIN, ARTHRALGIA AND URINARY INCONTINENCE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ALLERGY TO METALS, ANXIETY, ARTHRALGIA, BACK PAIN, BLISTER, CERVICITIS, DENTAL CARIES, DRY SKIN, DYSMENORRHOEA, EMBEDDED DEVICE, ERYTHEMA, FATIGUE, FUNGAL INFECTION, INFLAMMATION, JOINT SWELLING, MENORRHAGIA, PAIN, SALPINGITIS, SKIN DISCOLOURATION, SKIN DISORDER, SKIN IRRITATION, SWELLING, TOOTH DISORDER, URINARY INCONTINENCE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. PATIENT TOLERATED THE INSERTION PROCEDURE WELL. THE COIL IS DEEPLY EMBEDDED IN THE TISSUE, MAKING REMOVAL QUITE DIFFICULT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.7 KG/SQM. HYSTEROSALPINGOGRAM - ON 16-AUG-2014: RESULTS: CONFIRMING FULL OCCLUSION FALLOPIAN TUBE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: PELVC PAIN, SALPINGITIS, EMBEDDED DEVICE QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('THE COILS WERE DEEPLY EMBEDDED IN THE FALLOPIAN TUBE TISSUE, AT THE JUNCTION WITH THE UTERUS'), ABDOMINAL PAIN LOWER ('SEVERE ABDOMINAL CRAMPING'), SALPINGITIS ('SALPINGITIS') AND INFLAMMATION ('INFLAMMATION,') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 954893-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2 ((B)(6) 1991,(B)(6) 1996), MISCARRIAGE AND APPENDECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED JOINT SWELLING, OVERACTIVE BLADDER, FIBROSIS, ACUTE APPENDICITIS AND OBESITY. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED URINARY INCONTINENCE ("URINARY INCONTINENCE"). ON (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("CHRONIC FATIGUE"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/PROLONGED MENSTRUATION/ABNORMAL MENSTRUATION"), DENTAL CARIES ("TOOTH DECAY"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), FUNGAL INFECTION ("YEAST INFECTION"), TOOTH DISORDER ("DENTAL PROBLEMS") AND ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("ABDOMINAL BLOATING") AND VAGINAL INFECTION ("CHRONIC VAGINAL INFECTIONS") WITH VAGINAL DISCHARGE. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN/DYSMENORRHEA (CRAMPING)"), SKIN IRRITATION ("SKIN IRRITATION") WITH RASH, ERYTHEMA ("REDNESS"), SKIN DISORDER ("SKIN BUMPS"), DRY SKIN ("DRYNESS OF SKIN"), SKIN DISCOLOURATION ("PATCHES RESEMBLING BURN MARKS"), ANXIETY ("EMOTIONAL ANGUISH") AND BLISTER ("BLISTERS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED INFLAMMATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("SEVERE LOWER BACK PAIN / LOWER BACK PAIN/PHYSICAL PAIN"), SWELLING ("BODY SWELLING") AND JOINT SWELLING ("JOINT SWELLING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHRALGIA ("HIP PAIN/ SEVERE JOINT PAIN/ KNEE PAIN"), PAIN ("WAIST PAIN"), ADENOMYOSIS ("ENDOMETRIOSIS OF UTERUS") AND CERVICITIS ("INFLAMMATORY DISEASE OF CERVIX UTERI"). THE PATIENT WAS TREATED WITH IBUPROFEN, AND SURGERY (ON (B)(6) 2016,TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY /BILATERAL SALPINGECTOMY - TOTAL LAPAROS AND APPENDECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, ABDOMINAL PAIN LOWER, SALPINGITIS, DYSMENORRHOEA, ABDOMINAL DISTENSION, VAGINAL INFECTION, SKIN IRRITATION, ERYTHEMA, SKIN DISORDER, DRY SKIN, SKIN DISCOLOURATION, FATIGUE, WEIGHT INCREASED, MENORRHAGIA, DENTAL CARIES, VAGINAL HAEMORRHAGE, FUNGAL INFECTION, TOOTH DISORDER, ALLERGY TO METALS, PAIN, ANXIETY, BLISTER, ADENOMYOSIS, CERVICITIS, SWELLING AND JOINT SWELLING OUTCOME WAS UNKNOWN AND THE INFLAMMATION, BACK PAIN, ARTHRALGIA AND URINARY INCONTINENCE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ALLERGY TO METALS, ANXIETY, ARTHRALGIA, BACK PAIN, BLISTER, CERVICITIS, DENTAL CARIES, DRY SKIN, DYSMENORRHOEA, EMBEDDED DEVICE, ERYTHEMA, FATIGUE, FUNGAL INFECTION, INFLAMMATION, JOINT SWELLING, MENORRHAGIA, PAIN, SALPINGITIS, SKIN DISCOLOURATION, SKIN DISORDER, SKIN IRRITATION, SWELLING, TOOTH DISORDER, URINARY INCONTINENCE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. PATIENT TOLERATED THE INSERTION PROCEDURE WELL. THE COIL IS DEEPLY EMBEDDED IN THE TISSUE, MAKING REMOVAL QUITE DIFFICULT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: RESULTS: CONFIRMING FULL OCCLUSION FALLOPIAN TUBE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: PELVC PAIN, SALPINGITIS, EMBEDDED DEVICE. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THE EVENT "OVARIES AND UTERINE CANCER STARTS IN THE FALLOPIAN TUBES " REMOVED AS PER MAIL COMMUNICATION ,SIGNIFICANT AMENDMENT. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING") AND INFLAMMATION ("INFLAMMATION,") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 954893) 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) 1991, (B)(6) 1996 AND MISCARRIAGE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("CHRONIC FATIGUE"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/PROLONGED MENSTRUATION/ABNORMAL MESTRUATION"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), FUNGAL INFECTION ("YEAST INFECTION"), TOOTH DISORDER ("DENTAL PROBLEMS") AND ALLERGY TO METALS ("NICKEL ALLERGY") WITH RASH. ON 31-AUG-2016, THE PATIENT EXPERIENCED INFLAMMATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"), BACK PAIN ("SEVERE LOWER BACK PAIN / LOWER BACK PAIN"), ARTHRALGIA ("HIP PAIN/ SEVERE JOINT PAIN/ KNEE PAIN"), VAGINAL INFECTION ("CHRONIC VAGINAL INFECTIONS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), SKIN IRRITATION ("SKIN IRRITATION"), ERYTHEMA ("REDNESS"), SKIN DISORDER ("SKIN BUMPS"), DRY SKIN ("DRYNESS OF SKIN"), SKIN DISCOLOURATION ("PATCHES RESEMBLING BURN MARKS AND BLISTERS"), DENTAL CARIES ("TOOTH DECAY"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY TRACT PROBLEM") AND PAIN ("WAIST PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ON 14OCT2016,TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY /BILATERAL SALPINGECTOMY - TOTAL LAPAROS) AND SURGERY (APPENDECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, INFLAMMATION, DYSMENORRHOEA, ABDOMINAL DISTENSION, VAGINAL INFECTION, VAGINAL DISCHARGE, SKIN IRRITATION, ERYTHEMA, SKIN DISORDER, DRY SKIN, SKIN DISCOLOURATION, FATIGUE, WEIGHT INCREASED, MENORRHAGIA, DENTAL CARIES, VAGINAL HAEMORRHAGE, FUNGAL INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, ALLERGY TO METALS AND PAIN OUTCOME WAS UNKNOWN AND THE BACK PAIN AND ARTHRALGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, DENTAL CARIES, DRY SKIN, DYSMENORRHOEA, ERYTHEMA, FATIGUE, FUNGAL INFECTION, INFLAMMATION, MENORRHAGIA, PAIN, SKIN DISCOLOURATION, SKIN DISORDER, SKIN IRRITATION, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: CONFIRMING FULL OCCLUSION FALLOPIAN TUBE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED. REPORTER AND PATIENT DEMOGRAPHICS WERE ADDED. HISTORICAL CONDITION, HISTORICAL DRUG, WERE ADDED. UPDATED SUSPECT DRUG INDICATION AND LOT NUMBER. EVENTS VAGINAL BLEEDING, YEAST INFECTION, SKIN RASHES, BLADDER PROBLEM, URINARY TRACT PROBLEM, DENTAL PROBLEMS, NICKEL ALLERGY, INFLAMMATION, HIPS PAIN / KNEES PAIN AND WAIST PAIN WERE ADDED AND EVENT OUTCOME 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 ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"), BACK PAIN ("SEVERE LOWER BACK PAIN"), ARTHRALGIA ("HIP PAIN/ SEVERE JOINT PAIN"), VAGINAL INFECTION ("CHRONIC VAGINAL INFECTIONS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), SKIN IRRITATION ("SKIN IRRITATION"), RASH ("RASHES"), ERYTHEMA ("REDNESS"), SKIN DISORDER ("SKIN BUMPS"), DRY SKIN ("DRYNESS OF SKIN"), SKIN DISCOLOURATION ("PATCHES RESEMBLING BURN MARKS AND BLISTERS"), FATIGUE ("CHRONIC FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/PROLONGED MENSTRUATION/ABNORMAL MENSTRUATION") AND DENTAL CARIES ("TOOTH DECAY"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, DYSMENORRHOEA, ABDOMINAL DISTENSION, BACK PAIN, ARTHRALGIA, VAGINAL INFECTION, VAGINAL DISCHARGE, SKIN IRRITATION, RASH, ERYTHEMA, SKIN DISORDER, DRY SKIN, SKIN DISCOLOURATION, FATIGUE, WEIGHT INCREASED, MENORRHAGIA AND DENTAL CARIES OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ARTHRALGIA, BACK PAIN, DENTAL CARIES, DRY SKIN, DYSMENORRHOEA, ERYTHEMA, FATIGUE, MENORRHAGIA, RASH, SKIN DISCOLOURATION, SKIN DISORDER, SKIN IRRITATION, VAGINAL DISCHARGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: CONFIRMING FULL OCCLUSION FALLOPIAN TUBE INCIDENT. 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 |
|---|---|---|---|---|---|---|---|
| 730590 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 954893-NOT VALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other| R |