ESSURE
Report
- Report Number
- 2951250-2019-05161
- Event Type
- Injury
- Date Received
- August 29, 2019
- Report Date
- August 19, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('EXTRUSION'), PELVIC PAIN ('PAIN /PELVIC PAIN'), GENITAL HAEMORRHAGE ('BLEEDING') AND AUTOIMMUNE DISORDER ('AUTOIMMUNE-LIKE SYMPTOMS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 740659 , 5050053) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, MENSES IRREGULAR, FATIGUE, ANXIETY, POST COITAL BLEEDING, BLEEDING INTERMENSTRUAL, OVARIAN CYST, MENOMETRORRHAGIA, HOT FLASHES, UNILATERAL LEG PAIN, SINUS CONGESTION, DEPRESSION, POLYDIPSIA, FEELING COLD, JOINT PAIN, HEADACHE, COUGH, BACK PAIN, VULVAL LESION, PYURIA, UTI, FEVER, BLOOD IN STOOL, URGENCY URINATION, POLLAKIURIA, CONSTIPATION, POLYURIA, ITCHING, ABDOMINAL PAIN, DERMAL INCLUSION CYST, VAGINAL BLEEDING, OLIGOMENORRHOEA, NAUSEA, WEIGHT LOSS, GERD, TICK BITE AND POLYMENORRHOEA. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE;ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA"), ANAEMIA ("ANEMIA") AND MENORRHAGIA ("EXCESSIVE MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY, BILATERAL SALPINGECTOMY AND ESSURE COIL REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, AUTOIMMUNE DISORDER, DYSPAREUNIA, ANAEMIA AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANAEMIA, AUTOIMMUNE DISORDER, DEVICE DISLOCATION, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 7. MICRO INSERTS IN THE OPPOSITE TUBES TRAILING INTO THE UTERINE CAVITY WAS 3. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2010: SHOWS SYMMETRIC , POSITION TO FALLOPIAN TUBE COILS IN THE PELVIS. THERE IS NO EVIDENCE OF FLOW ALONG THE FALLOPIAN TUBE. PATHOLOGY TEST - ON (B)(6) 2018: FALLOPIAN TUBE, RIGHT, SALPINGECTOMY: BENIGN FALLOPIAN TUBE TISSUE WITH COMPLETE SURGICAL INTERRUPTION. NEGATIVE FOR DYSPLASIA AND MALIGNANCY. FALLOPIAN TUBE, LEFT, SALPINGECTOMY: FALLOPIAN TUBE TISSUE WITH COMPLETE SURGICAL INTERRUPTION. THERE IS ASSOCIATED CONGESTION. THERE IS-A COILED METALLIC DEVICE IN THE LUMEN OF THE FALLOPIAN TUBE. NEGATIVE FOR DYSPLASIA AND MALIGNANCY. LEFT FALLOPIAN TUBE: RECEIVED UNFIXED IN A CONTAINER LABELED WITH THE PATIENT'S NAME 1S A SEGMENT OF FALLOPIAN TUBE AND FIMBRIATED END, MEASURING 7.5 CM IN LENGTH AND 0. 8 CM IN DIAMETER. EXTENDING FROM THE LUMEN OF THE FALLOPIAN TUBE IS A COILED PIECE OF SURGICAL HARDWARE. ON HYSTEROSCOPY: UTERUS SOUNDED 8 CM, ESSURE COILS NOTED TO EXTRUDE THROUGH THE RIGHT FALLOPIAN TUBE OPENING THE ESSURE COILS WERE REMOVED WITH THIS AS WELL CONFIRMING THAT THE ENTIRE ESSURE COIL WAS REMOVED.. PREGNANCY TEST URINE - ON (B)(6) 2010: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN,MENORRHAGIA ,ANEMIA ,ESSURE COILS NOTED TO EXTRUDE THROUGH THE RIGHT FALLOPIAN TUBE OPENING. LOT NUMBER: 5050053 MANUFACTURE DATE:2010-05 EXPIRATION DATE: 2013-05. LOT NUMBER:740659 MANUFACTURE DATE: 2010-02 EXPIRATION DATE: 2013-02. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-SEP-2019: QUALITY SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL COMPLAINT). INCIDENT: WE RECEIVED A LOT NUMBER. 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 DEVICE DISLOCATION ('EXTRUSION') AND PELVIC PAIN ('PAIN /PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 740659,5050053,50500531) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, MENSES IRREGULAR, FATIGUE, ANXIETY, POST COITAL BLEEDING, BLEEDING INTERMENSTRUAL, OVARIAN CYST, MENOMETRORRHAGIA, HOT FLASHES, UNILATERAL LEG PAIN, SINUS CONGESTION, DEPRESSION, POLYDIPSIA, FEELING COLD, JOINT PAIN, HEADACHE, COUGH, BACK PAIN, VULVAL LESION, PYURIA, UTI, FEVER, BLOOD IN STOOL, URGENCY URINATION, POLLAKIURIA, CONSTIPATION, POLYURIA, ITCHING, ABDOMINAL PAIN, DERMAL INCLUSION CYST, VAGINAL BLEEDING, OLIGOMENORRHOEA, NAUSEA, WEIGHT LOSS, GERD, TICK BITE AND POLYMENORRHOEA. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE;ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("BLEEDING"), AUTOIMMUNE DISORDER ("AUTOIMMUNE-LIKE SYMPTOMS"), DYSPAREUNIA ("DYSPAREUNIA"), ANAEMIA ("ANEMIA") AND MENORRHAGIA ("EXCESSIVE MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY, BILATERAL SALPINGECTOMY AND ESSURE COIL REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, AUTOIMMUNE DISORDER, DYSPAREUNIA, ANAEMIA AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANAEMIA, AUTOIMMUNE DISORDER, DEVICE DISLOCATION, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 7. MICRO INSERTS IN THE OPPOSITE TUBES TRAILING INTO THE UTERINE CAVITY WAS 3. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2010: SHOWS SYMMETRIC , POSITION TO FALLOPIAN TUBE COILS IN THE PELVIS. THERE IS NO EVIDENCE OF FLOW ALONG THE FALLOPIAN TUBE. PATHOLOGY TEST - ON (B)(6) 2018: FALLOPIAN TUBE, RIGHT, SALPINGECTOMY: BENIGN FALLOPIAN TUBE TISSUE WITH COMPLETE SURGICAL INTERRUPTION. NEGATIVE FOR DYSPLASIA AND MALIGNANCY. FALLOPIAN TUBE, LEFT, SALPINGECTOMY: FALLOPIAN TUBE TISSUE WITH COMPLETE SURGICAL INTERRUPTION. THERE IS ASSOCIATED CONGESTION. THERE IS-A COILED METALLIC DEVICE IN THE LUMEN OF THE FALLOPIAN TUBE. NEGATIVE FOR DYSPLASIA AND MALIGNANCY. LEFT FALLOPIAN TUBE: RECEIVED UNFIXED IN A CONTAINER LABELED WITH THE PATIEN¿'S NAME 1S A SEGMENT OF FALLOPIAN TUBE AND FIMBRIATED END, MEASURING 7.5 CM IN LENGTH AND 0. 8 CM IN DIAMETER. EXTENDING FROM THE LUMEN OF THE FALLOPIAN TUBE IS A COILED PIECE OF SURGICAL HARDWARE.ON HYSTEROSCOPY: UTERUS SOUNDED 8 CM, ESSURE COILS NOTED TO EXTRUDE THROUGH THE RIGHT FALLOPIAN TUBE OPENINGTHE ESSURE COILS WERE REMOVED WITH THIS AS WELL CONFIRMING THAT THE ENTIRE ESSURE COIL WAS REMOVED.. PREGNANCY TEST URINE - ON (B)(6) 2010: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN,MENORRHAGIA ,ANEMIA ,ESSURE COILS NOTED TO EXTRUDE THROUGH THE RIGHT FALLOPIAN TUBE OPENING. LOT NUMBER: 5050053 MANUFACTURE DATE:2010-05 EXPIRATION DATE: 2013-05 . LOT NUMBER:740659 MANUFACTURE DATE: 2010-02 EXPIRATION DATE: 2013-02 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-JUL-2020: MR RECEIVED: LOT NUMBER ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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 ('EXTRUSION') AND PELVIC PAIN ('PAIN /PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 740659, 5050053, 50500531) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, MENSES IRREGULAR, FATIGUE, ANXIETY, POST COITAL BLEEDING, BLEEDING INTERMENSTRUAL, OVARIAN CYST, MENOMETRORRHAGIA, HOT FLASHES, UNILATERAL LEG PAIN, SINUS CONGESTION, DEPRESSION, POLYDIPSIA, FEELING COLD, JOINT PAIN, HEADACHE, COUGH, BACK PAIN, VULVAL LESION, PYURIA, UTI, FEVER, BLOOD IN STOOL, URGENCY URINATION, POLLAKIURIA, CONSTIPATION, POLYURIA, ITCHING, ABDOMINAL PAIN, DERMAL INCLUSION CYST, VAGINAL BLEEDING, OLIGOMENORRHOEA, NAUSEA, WEIGHT LOSS, GERD, TICK BITE AND POLYMENORRHOEA. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE; ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("BLEEDING"), AUTOIMMUNE DISORDER ("AUTOIMMUNE-LIKE SYMPTOMS"), DYSPAREUNIA ("DYSPAREUNIA"), ANAEMIA ("ANEMIA") AND MENORRHAGIA ("EXCESSIVE MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY, BILATERAL SALPINGECTOMY AND ESSURE COIL REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, AUTOIMMUNE DISORDER, DYSPAREUNIA, ANAEMIA AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANAEMIA, AUTOIMMUNE DISORDER, DEVICE DISLOCATION, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 7. MICRO INSERTS IN THE OPPOSITE TUBES TRAILING INTO THE UTERINE CAVITY WAS 3. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: ON (B)(6) 2010: SHOWS SYMMETRIC , POSITION TO FALLOPIAN TUBE COILS IN THE PELVIS. THERE IS NO EVIDENCE OF FLOW ALONG THE FALLOPIAN TUBE. PATHOLOGY TEST: ON (B)(6) 2018: FALLOPIAN TUBE, RIGHT, SALPINGECTOMY: BENIGN FALLOPIAN TUBE TISSUE WITH COMPLETE SURGICAL INTERRUPTION. NEGATIVE FOR DYSPLASIA AND MALIGNANCY. FALLOPIAN TUBE, LEFT, SALPINGECTOMY: FALLOPIAN TUBE TISSUE WITH COMPLETE SURGICAL INTERRUPTION. THERE IS ASSOCIATED CONGESTION. THERE IS-A COILED METALLIC DEVICE IN THE LUMEN OF THE FALLOPIAN TUBE. NEGATIVE FOR DYSPLASIA AND MALIGNANCY. LEFT FALLOPIAN TUBE: RECEIVED UNFIXED IN A CONTAINER LABELED WITH THE PATIENT'S NAME IS A SEGMENT OF FALLOPIAN TUBE AND FIMBRIATED END, MEASURING 7.5 CM IN LENGTH AND 0. 8 CM IN DIAMETER. EXTENDING FROM THE LUMEN OF THE FALLOPIAN TUBE IS A COILED PIECE OF SURGICAL HARDWARE. ON HYSTEROSCOPY: UTERUS SOUNDED 8 CM, ESSURE COILS NOTED TO EXTRUDE THROUGH THE RIGHT FALLOPIAN TUBE OPENING THE ESSURE COILS WERE REMOVED WITH THIS AS WELL CONFIRMING THAT THE ENTIRE ESSURE COIL WAS REMOVED.. PREGNANCY TEST URINE: ON (B)(6) 2010: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, MENORRHAGIA, ANEMIA, ESSURE COILS NOTED TO EXTRUDE THROUGH THE RIGHT FALLOPIAN TUBE OPENING. LOT NUMBER: 50500531, MANUFACTURING DATE: 2010-02, EXPIRATION DATE: 2013-02. LOT NUMBER: 5050053, MANUFACTURING DATE: 2010-02, EXPIRATION DATE: 2013-02. LOT NUMBER: 740659, MANUFACTURING DATE: 2010-05, EXPIRATION DATE: 2013-05. LOT NUMBER: 5050053, MANUFACTURE DATE: 2010-05, EXPIRATION DATE: 2013-05. LOT NUMBER: 740659, MANUFACTURE DATE: 2010-02, EXPIRATION DATE: 2013-02. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-AUG-2020: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). A TECHNICAL INVESTIGATION WAS 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 ('EXTRUSION'), PELVIC PAIN ('PAIN /PELVIC PAIN') AND GENITAL HAEMORRHAGE ('BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 740659 RT, 5050053 LT) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, MENSES IRREGULAR, FATIGUE, ANXIETY, POST COITAL BLEEDING, BLEEDING INTERMENSTRUAL, OVARIAN CYST, MENOMETRORRHAGIA, HOT FLASHES, UNILATERAL LEG PAIN, SINUS CONGESTION, DEPRESSION, POLYDIPSIA, FEELING COLD, JOINT PAIN, HEADACHE, COUGH, BACK PAIN, VULVAL LESION, PYURIA, UTI, FEVER, BLOOD IN STOOL, URGENCY URINATION, POLLAKIURIA, CONSTIPATION, POLYURIA, ITCHING, ABDOMINAL PAIN, DERMAL INCLUSION CYST, VAGINAL BLEEDING, OLIGOMENORRHOEA, NAUSEA, WEIGHT LOSS, GERD, TICK BITE AND POLYMENORRHOEA. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE; ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA"), AUTOIMMUNE DISORDER ("AUTOIMMUNE-LIKE SYMPTOMS"), ANAEMIA ("ANEMIA") AND MENORRHAGIA ("EXCESSIVE MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY, BILATERAL SALPINGECTOMY AND ESSURE COIL REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA, AUTOIMMUNE DISORDER, ANAEMIA AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANAEMIA, AUTOIMMUNE DISORDER, DEVICE DISLOCATION, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 7. MICRO INSERTS IN THE OPPOSITE TUBES TRAILING INTO THE UTERINE CAVITY WAS 3. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2010: SHOWS SYMMETRIC , POSITION TO FALLOPIAN TUBE COILS IN THE PELVIS. THERE IS NO EVIDENCE OF FLOW ALONG THE FALLOPIAN TUBE. PATHOLOGY TEST - ON (B)(6) 2018: FALLOPIAN TUBE, RIGHT, SALPINGECTOMY: BENIGN FALLOPIAN TUBE TISSUE WITH COMPLETE SURGICAL INTERRUPTION. NEGATIVE FOR DYSPLASIA AND MALIGNANCY. FALLOPIAN TUBE, LEFT, SALPINGECTOMY: FALLOPIAN TUBE TISSUE WITH COMPLETE SURGICAL INTERRUPTION. THERE IS ASSOCIATED CONGESTION. THERE IS-A COILED METALLIC DEVICE IN THE LUMEN OF THE FALLOPIAN TUBE. NEGATIVE FOR DYSPLASIA AND MALIGNANCY. LEFT FALLOPIAN TUBE: RECEIVED UNFIXED IN A CONTAINER LABELED WITH THE PATIENT'S NAME IS A SEGMENT OF FALLOPIAN TUBE AND FIMBRIATED END, MEASURING 7.5 CM IN LENGTH AND 0. 8 CM IN DIAMETER. EXTENDING FROM THE LUMEN OF THE FALLOPIAN TUBE IS A COILED PIECE OF SURGICAL HARDWARE. ON HYSTEROSCOPY: UTERUS SOUNDED 8 CM, ESSURE COILS NOTED TO EXTRUDE THROUGH THE RIGHT FALLOPIAN TUBE OPENING THE ESSURE COILS WERE REMOVED WITH THIS AS WELL CONFIRMING THAT THE ENTIRE ESSURE COIL WAS REMOVED.. PREGNANCY TEST URINE - ON (B)(6) 2010: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN,MENORRHAGIA ,ANEMIA ,ESSURE COILS NOTED TO EXTRUDE THROUGH THE RIGHT FALLOPIAN TUBE OPENING. INCIDENT. WE RECEIVED A LOT NUMBER. 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 |
|---|---|---|---|---|---|---|---|
| 737208 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 740659,5050053,50500531 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | YAZ.| YAZ.| YAZ.| YAZ. |