ESSURE
Report
- Report Number
- 2951250-2018-03257
- Event Type
- Injury
- Date Received
- July 30, 2018
- Date of Event
- December 1, 2017
- Report Date
- May 24, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
E WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5035759) ON 27-MAY-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 21-AUG-2018. THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY"), ABORTION SPONTANEOUS ("MISCARRIAGE") AND MENORRHAGIA ("CYCLES THAT HAVE LASTED 8 AND 9 DAYS AND HAVING 2 A MONTH") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 844600) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ASTHMA. CONCURRENT CONDITIONS INCLUDED OBESITY AND FATIGUE. CONCOMITANT PRODUCTS INCLUDED BENZATHINE BENZYLPENICILLIN (PENICILLIN G BENZATHINE) FOR HIVES AS WELL AS NSAID'S SINCE 2011 AND PARACETAMOL (ACETAMINOPHEN) SINCE 2011. ON AN UNKNOWN DATE, THE PATIENT STARTED DURICEF AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, 6 YEARS 5 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("SEVERE PELVIC PAIN"), HYPOAESTHESIA ("NUMBNESS IN ARMS AND LEGS"), ABDOMINAL PAIN LOWER ("LOTS OF LOWER ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("SHARP, SHOOTING, LOWER VAGINAL PAIN"), BACK PAIN ("LOWER BACK PAIN"), THE FIRST EPISODE OF HEADACHE ("HEADACHE"), FEELING ABNORMAL ("FOGGY MIND"), POLYMENORRHOEA ("CYCLES THAT HAVE LASTED 8 AND 9 DAYS AND HAVING 2 A MONTH"), INFECTION ("INFECTIONS"), WEIGHT INCREASED ("WEIGHT GAIN"), HYPERSENSITIVITY ("ALLERGIC REACTION"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), MIGRAINE ("MIGRAINES"), THE SECOND EPISODE OF HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, PELVIC PAIN, INFECTION, WEIGHT INCREASED, HYPERSENSITIVITY AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, HYPOAESTHESIA, ABDOMINAL PAIN LOWER, VULVOVAGINAL PAIN, BACK PAIN, FEELING ABNORMAL, POLYMENORRHOEA, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, MIGRAINE, THE LAST EPISODE OF HEADACHE, DYSMENORRHOEA AND DYSPAREUNIA HAD NOT RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN LOWER, BACK PAIN, FEELING ABNORMAL, HYPOAESTHESIA, MENORRHAGIA, POLYMENORRHOEA, VULVOVAGINAL PAIN AND THE FIRST EPISODE OF HEADACHE WITH ESSURE. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, HYPERSENSITIVITY, INFECTION, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, WEIGHT INCREASED AND THE SECOND EPISODE OF HEADACHE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT UNDERWENT TREATMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33.5 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-AUG-2018: QUALITY-SAFETY EVALUATION OF PTC (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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5035759) ON 27-MAY-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 17-MAY-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('CYCLES THAT HAVE LASTED 8 AND 9 DAYS AND HAVING 2 A MONTH'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY') AND ABORTION SPONTANEOUS ('MISCARRIAGE') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 844600) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED DURICEF FOR HIVES. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED ASTHMA. CONCURRENT CONDITIONS INCLUDED OBESITY AND FATIGUE. CONCOMITANT PRODUCTS INCLUDED BENZATHINE BENZYLPENICILLIN (PENICILLIN G BENZATHINE) FOR HIVES AS WELL AS MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2011 TO (B)(6) 2012, NSAIDS SINCE (B)(6) 2011 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2011. ON AN UNKNOWN DATE, THE PATIENT STARTED DURICEF AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED INFECTION ("INFECTIONS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), ALLERGY TO METALS ("NICKEL ALLERGY"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2013, THE PATIENT EXPERIENCED HYPERSENSITIVITY ("ALLERGIC REACTION,HORMONAL CHANGES DESCRIBE: SUPER SENSITIVE"). IN 2014, THE PATIENT EXPERIENCED HYPOAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE:NUMBNESS IN ARMS AND LEGS"). ON (B)(6) 2017, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 6 YEARS 5 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("SEVERE PELVIC PAIN"), ABDOMINAL PAIN LOWER ("LOTS OF LOWER ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("SHARP, SHOOTING, LOWER VAGINAL PAIN"), BACK PAIN ("LOWER BACK PAIN"), THE FIRST EPISODE OF HEADACHE ("HEADACHE"), FEELING ABNORMAL ("FOGGY MIND"), POLYMENORRHOEA ("CYCLES THAT HAVE LASTED 8 AND 9 DAYS AND HAVING 2 A MONTH"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), MIGRAINE ("MIGRAINES"), THE SECOND EPISODE OF HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), PAIN IN EXTREMITY ("LEGS PAIN"), ADNEXA UTERI PAIN ("OVARIES PAIN") AND URINARY TRACT INFECTION ("URINARY TRACT INFECTION"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, HYPOAESTHESIA, ABDOMINAL PAIN LOWER, VULVOVAGINAL PAIN, BACK PAIN, FEELING ABNORMAL, POLYMENORRHOEA, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, MIGRAINE, THE LAST EPISODE OF HEADACHE, DYSMENORRHOEA AND DYSPAREUNIA HAD NOT RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, PELVIC PAIN, INFECTION, WEIGHT INCREASED, HYPERSENSITIVITY, MENSTRUAL DISORDER, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, ALLERGY TO METALS, VAGINAL DISCHARGE, VISION BLURRED, FATIGUE, PAIN IN EXTREMITY, ADNEXA UTERI PAIN AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE AND DURICEF OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN LOWER, BACK PAIN, FEELING ABNORMAL, HYPOAESTHESIA, MENORRHAGIA, POLYMENORRHOEA, VULVOVAGINAL PAIN AND THE FIRST EPISODE OF HEADACHE WITH ESSURE. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, ADNEXA UTERI PAIN, ALLERGY TO METALS, ANXIETY, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HYPERSENSITIVITY, INFECTION, MENSTRUAL DISORDER, MIGRAINE, PAIN IN EXTREMITY, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED, WEIGHT INCREASED AND THE SECOND EPISODE OF HEADACHE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT UNDERWENT TREATMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE. SHE WILL CURRENTLY PLANNING FOR ESSURE REMOVAL YES DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33.5 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: OTHER (PLEASE DESCRIBE) DOES NOT RECALL.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-MAY-2019: PLAINTIFF FACT SHEET RECEIVED, NEW REPORTER AND THE EVENTS HORMONAL CHANGES DESCRIBE: SUPER SENSITIVE CLUBBED WITH ALLERGIC REACTION, NEW EVENTS INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), BLADDER OR URINARY PROBLEMS OR CHANGES, NICKEL ALLERGY, VAGINAL DISCHARGE, VISION/EYE PROBLEMS TYPE: BLURRED VISION, FATIGUE LEGS PAIN, OVARIES PAIN AND 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-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY"), ABORTION SPONTANEOUS ("MISCARRIAGE") AND MENORRHAGIA ("CYCLES THAT HAVE LASTED 8 AND 9 DAYS AND HAVING 2 A MONTH") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 844600) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ASTHMA. CONCURRENT CONDITIONS INCLUDED OBESITY AND FATIGUE. CONCOMITANT PRODUCTS INCLUDED BENZATHINE BENZYLPENICILLIN (PENICILLIN G BENZATHINE) FOR HIVES AS WELL AS NSAID'S SINCE 2011 AND PARACETAMOL (ACETAMINOPHEN) SINCE 2011. ON AN UNKNOWN DATE, THE PATIENT STARTED DURICEF AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, 6 YEARS 5 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("SEVERE PELVIC PAIN"), HYPOAESTHESIA ("NUMBNESS IN ARMS AND LEGS"), ABDOMINAL PAIN LOWER ("LOTS OF LOWER ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("SHARP, SHOOTING, LOWER VAGINAL PAIN"), BACK PAIN ("LOWER BACK PAIN"), THE FIRST EPISODE OF HEADACHE ("HEADACHE"), FEELING ABNORMAL ("FOGGY MIND"), POLYMENORRHOEA ("CYCLES THAT HAVE LASTED 8 AND 9 DAYS AND HAVING 2 A MONTH"), INFECTION ("INFECTIONS"), WEIGHT INCREASED ("WEIGHT GAIN"), HYPERSENSITIVITY ("ALLERGIC REACTION"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), MIGRAINE ("MIGRAINES"), THE SECOND EPISODE OF HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (ABLATION). AT THE TIME OF THE REPORT, THE PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, PELVIC PAIN, INFECTION, WEIGHT INCREASED, HYPERSENSITIVITY AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, HYPOAESTHESIA, ABDOMINAL PAIN LOWER, VULVOVAGINAL PAIN, BACK PAIN, FEELING ABNORMAL, POLYMENORRHOEA, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, MIGRAINE, THE LAST EPISODE OF HEADACHE, DYSMENORRHOEA AND DYSPAREUNIA HAD NOT RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN LOWER, BACK PAIN, FEELING ABNORMAL, HYPOAESTHESIA, MENORRHAGIA, POLYMENORRHOEA, VULVOVAGINAL PAIN AND THE FIRST EPISODE OF HEADACHE WITH ESSURE. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, HYPERSENSITIVITY, INFECTION, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, WEIGHT INCREASED AND THE SECOND EPISODE OF HEADACHE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT UNDERWENT TREATMENT DUE TO COMPLICATIONS FROM THE ESSURE DEVICE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JUL-2018: PFS AND MR RECEIVED. REPORTER INFORMATION ADDED. HISTORICAL CONDITION, CONCOMITANT CONDITION CONCOMITANT DRUG WERE ADDED. ADDED EVENT ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), DEPRESSION, MENTAL ANGUISH, MIGRAINES, HEADACHES, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE).UPDATED ONSET DATE, OUTCOME. UPDATED INCIDENT CATEGORY. LOT NUMBER 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573500 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 844600 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| DEPO PROVERA| NSAID'S| NSAID'S| NSAIDS| PENICILLIN G BENZATHINE| PENICILLIN G BENZATHINE| PENICILLIN G BENZATHINE |