ESSURE
Report
- Report Number
- 2951250-2017-07812
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- July 1, 2006
- Report Date
- February 13, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 509813) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BREAST CYST, ABDOMINAL LYMPHADENOPATHY, PTOSIS OF EYELID AND BUNION. CONCOMITANT PRODUCTS INCLUDED ACICLOVIR (ACYCLOVIR [ACICLOVIR]), BUPROPION (WELLBUTRIN) UNTIL (B)(6) 2012, DEXMETHYLPHENIDATE HYDROCHLORIDE (FOCALIN) SINCE 2007 AND HERBAL DIURETIC FROM 2005 TO 2012. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2006, 12 DAYS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED THE FIRST EPISODE OF WEIGHT INCREASED ("WEIGHT GAIN"), FATIGUE ("FATIGUE"), DYSPAREUNIA ("DYSPAREUNIA") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN 2007, THE PATIENT EXPERIENCED MILIARIA ("RASH/RASHES OR SKIN CONDITIONS TYPE: RASHES ON ARMS, FEET, BACK, TRUNK WHEN EXPOSED TO HEAT"). IN 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HOT FLUSH ("HOT FLASHES"), THE SECOND EPISODE OF WEIGHT INCREASED ("WEIGHT GAIN"), ARTHRALGIA ("JOINT PAIN"), ABDOMINAL DISTENSION ("BLOATING") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HOT FLUSH, DYSPAREUNIA, VAGINAL DISCHARGE, THE LAST EPISODE OF WEIGHT INCREASED, ALOPECIA, ARTHRALGIA AND AUTOIMMUNE DISORDER OUTCOME WAS UNKNOWN, THE MILIARIA HAD RESOLVED AND THE FATIGUE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, ARTHRALGIA, AUTOIMMUNE DISORDER, DYSPAREUNIA, FATIGUE, HOT FLUSH, MILIARIA, PELVIC PAIN, VAGINAL DISCHARGE, THE FIRST EPISODE OF WEIGHT INCREASED AND THE SECOND EPISODE OF WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: SHE HAD NEED FOR ADDITIONAL SURGERY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED: REPORTERS, PATIENT DEMOGRAPHIC, ESSURE LOT NUMBER 509813, CONCOMITANT MEDICATIONS, HISTORICAL CONDITIONS AND EVENTS (WEIGHT GAIN, HAIR LOSS, VAGINAL DISCHARGE, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), HOT FLASHES, BLOATING, AUTOIMMUNE DISORDER TYPE OF DISORDER: BELIEVED TO BE MIXED CONNECTIVE TISSUE, ANA COUNTS DEVELOPED AND BECAME HIGH) 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 PELVIC PAIN ("PELVIC PAIN") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 509813) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BREAST CYST, ABDOMINAL LYMPHADENOPATHY, PTOSIS OF EYELID AND BUNION. CONCOMITANT PRODUCTS INCLUDED ACICLOVIR (ACYCLOVIR [ACICLOVIR]), BUPROPION (WELLBUTRIN) UNTIL MAY 2012, DEXMETHYLPHENIDATE HYDROCHLORIDE (FOCALIN) SINCE 2007 AND HERBAL DIURETIC FROM 2005 TO 2012. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2006, 12 DAYS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED THE FIRST EPISODE OF WEIGHT INCREASED ("WEIGHT GAIN"), FATIGUE ("FATIGUE"), DYSPAREUNIA ("DYSPAREUNIA") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN 2007, THE PATIENT EXPERIENCED MILIARIA ("RASH/RASHES OR SKIN CONDITIONS TYPE: RASHES ON ARMS, FEET, BACK, TRUNK WHEN EXPOSED TO HEAT"). IN 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HOT FLUSH ("HOT FLASHES"), THE SECOND EPISODE OF WEIGHT INCREASED ("WEIGHT GAIN"), ARTHRALGIA ("JOINT PAIN"), ABDOMINAL DISTENSION ("BLOATING") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HOT FLUSH, DYSPAREUNIA, VAGINAL DISCHARGE, THE LAST EPISODE OF WEIGHT INCREASED, ALOPECIA, ARTHRALGIA AND AUTOIMMUNE DISORDER OUTCOME WAS UNKNOWN, THE MILIARIA HAD RESOLVED AND THE FATIGUE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, ARTHRALGIA, AUTOIMMUNE DISORDER, DYSPAREUNIA, FATIGUE, HOT FLUSH, MILIARIA, PELVIC PAIN, VAGINAL DISCHARGE, THE FIRST EPISODE OF WEIGHT INCREASED AND THE SECOND EPISODE OF WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: SHE HAD NEED FOR ADDITIONAL SURGERY QUALITY-SAFETY EVALUATION OF PTC: UNABLE OT CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 509813) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BREAST CYST, ABDOMINAL LYMPHADENOPATHY, PTOSIS OF EYELID AND BUNION. CONCOMITANT PRODUCTS INCLUDED ACICLOVIR (ACYCLOVIR [ACICLOVIR]), BUPROPION (WELLBUTRIN) UNTIL (B)(6) 2012, DEXMETHYLPHENIDATE HYDROCHLORIDE (FOCALIN) SINCE 2007 AND HERBAL DIURETIC FROM 2005 TO 2012. IN 2006, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER"). IN (B)(6) 2006, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2006, 12 DAYS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED THE FIRST EPISODE OF WEIGHT INCREASED ("WEIGHT GAIN"), FATIGUE ("FATIGUE"), DYSPAREUNIA ("DYSPAREUNIA") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE/ HEAVY VAGINAL DISCHARGE"). ON (B)(6) 2006, THE PATIENT EXPERIENCED HOT FLUSH ("HOT FLASHES") AND NIGHT SWEATS ("NIGHT SWEATS"). IN 2007, THE PATIENT EXPERIENCED MILIARIA ("RASH/RASHES OR SKIN CONDITIONS TYPE: RASHES ON ARMS, FEET, BACK, TRUNK WHEN EXPOSED TO HEAT/RASH OVER BODY"), ARTHRALGIA ("JOINT PAIN") AND ECZEMA ("ECZEMA"). IN 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE SECOND EPISODE OF WEIGHT INCREASED ("WEIGHT GAIN") AND ABDOMINAL DISTENSION ("BLOATING"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),), SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)) AND SURGERY (ESSUR REMOVAL). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, HOT FLUSH, DYSPAREUNIA, VAGINAL DISCHARGE, THE LAST EPISODE OF WEIGHT INCREASED, ALOPECIA, ARTHRALGIA, AUTOIMMUNE DISORDER, NIGHT SWEATS AND ECZEMA OUTCOME WAS UNKNOWN, THE MILIARIA HAD RESOLVED AND THE FATIGUE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, ARTHRALGIA, AUTOIMMUNE DISORDER, DYSPAREUNIA, ECZEMA, FATIGUE, HOT FLUSH, MILIARIA, NIGHT SWEATS, PELVIC PAIN, VAGINAL DISCHARGE, THE FIRST EPISODE OF WEIGHT INCREASED AND THE SECOND EPISODE OF WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: SHE HAD NEED FOR ADDITIONAL SURGERY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE OT CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-OCT-2018: PLAINTIFF FACT SHEET- NEW EVENT LOWER ABDOMINAL PAIN, NIGHT SWEATS, ECZEMA, 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND ABDOMINAL PAIN LOWER ('LOWER ABDOMINAL PAIN') IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 509813) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE DISORDER NOS. CONCURRENT CONDITIONS INCLUDED BREAST CYST, ABDOMINAL LYMPHADENOPATHY, PTOSIS OF EYELID AND BUNION. CONCOMITANT PRODUCTS INCLUDED ACICLOVIR (ACYCLOVIR), BUPROPION HYDROCHLORIDE (WELLBUTRIN) UNTIL (B)(6) 2012, DEXMETHYLPHENIDATE HYDROCHLORIDE (FOCALIN) SINCE 2007 AND HERBAL DIURETIC FROM 2005 TO 2012. IN 2006, THE PATIENT EXPERIENCED CONNECTIVE TISSUE DISORDER ("AUTOIMMUNE DISORDER: MISCONNECTED TISSUE"). IN (B)(6) 2006, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2006, THE PATIENT WAS FOUND TO HAVE THE FIRST EPISODE OF WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED FATIGUE ("FATIGUE"), DYSPAREUNIA ("DYSPAREUNIA") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE/ HEAVY VAGINAL DISCHARGE"), 12 DAYS AFTER INSERTION OF ESSURE (ESS205). ON (B)(6) 2006, THE PATIENT EXPERIENCED HOT FLUSH ("HOT FLASHES") AND NIGHT SWEATS ("NIGHT SWEATS"). IN 2007, THE PATIENT EXPERIENCED MILIARIA ("RASH/RASHES OR SKIN CONDITIONS TYPE: RASHES ON ARMS, FEET, BACK, TRUNK WHEN EXPOSED TO HEAT/RASH OVER BODY"), THE FIRST EPISODE OF ARTHRALGIA ("JOINT PAIN"), ECZEMA ("ECZEMA"), BACK PAIN ("LOWER BACK PAIN"), PERIARTHRITIS ("FROZEN SHOULDER 5 YEARS AGO") AND DEPRESSION ("DEPRESSION"). IN 2012, THE PATIENT EXPERIENCED HAIR LOSS ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("BLOATING/MY ABDOMEN IS SWOLLEN ALL THE TIME AND I LOOK PREGNANT"), BREAST PAIN ("BREAST PAIN"), POSTMENOPAUSE ("POST MENOPAUSAL"), THE SECOND EPISODE OF ARTHRALGIA ("EXTREME JOINT PAIN"), LETHARGY ("EXTREME LETHARGY"), POOR QUALITY SLEEP ("INABILITY TO SLEEP"), HAIR THINNING ("HAIRS HAS BEEN THINNING"), SKIN ODOUR ABNORMAL ("BODY ODOUR"), DRY EYE ("DRY EYES"), DRY MOUTH ("DRY MOUTH"), URTICARIA ("UNEXPLAINED HIVES"), RASH ("RASHES") AND INFLAMMATION ("INFLAMMATION") AND WAS FOUND TO HAVE THE SECOND EPISODE OF WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL, SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES) AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, HOT FLUSH, DYSPAREUNIA, VAGINAL DISCHARGE, HAIR LOSS, CONNECTIVE TISSUE DISORDER, NIGHT SWEATS, ECZEMA, BACK PAIN, PERIARTHRITIS, DEPRESSION, BREAST PAIN, POSTMENOPAUSE, THE LAST EPISODE OF ARTHRALGIA, LETHARGY, POOR QUALITY SLEEP, HAIR THINNING, SKIN ODOUR ABNORMAL, DRY EYE, DRY MOUTH, URTICARIA AND RASH OUTCOME WAS UNKNOWN, THE MILIARIA HAD RESOLVED AND THE FATIGUE, THE LAST EPISODE OF WEIGHT INCREASED AND INFLAMMATION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, BACK PAIN, BREAST PAIN, CONNECTIVE TISSUE DISORDER, DEPRESSION, DRY EYE, DRY MOUTH, DYSPAREUNIA, ECZEMA, FATIGUE, HAIR LOSS, HOT FLUSH, INFLAMMATION, LETHARGY, MILIARIA, NIGHT SWEATS, PELVIC PAIN, PERIARTHRITIS, POOR QUALITY SLEEP, POSTMENOPAUSE, RASH, SKIN ODOUR ABNORMAL, URTICARIA, VAGINAL DISCHARGE, THE FIRST EPISODE OF ARTHRALGIA, THE FIRST EPISODE OF WEIGHT INCREASED, HAIR THINNING, THE SECOND EPISODE OF ARTHRALGIA AND THE SECOND EPISODE OF WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: SHE HAD NEED FOR ADDITIONAL SURGERY. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS SOCIAL MEDIA RECORD: ABDOMINAL DISTENSION, WEIGHT GAIN, PERIARTHRITIS, BACK PAIN, ECZEMA, AUTOIMMUNE DISORDER, DEPRESSION, BREAST PAIN, POST-MENOPAUSAL, EXTREME JOINT PAIN, EXTREME LETHARGY, INABILITY TO SLEEP, HAIRS HAS BEEN THINNING, BODY ODOR, DRY MOUTH/EYES, UNEXPLAINED HIVES, RASHES, INFLAMMATION". QUALITY-SAFETY EVALUATION OF PTC: UNABLE OT CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JAN-2020: INFORMATION RECEIVED VIA SOCIAL MEDIA. EVENTS¿ ECZEMA, LOW BACK PAIN, FROZEN SHOULDER 5 YEARS AGO, DEPRESSION, BREAST PAIN, POST-MENOPAUSAL, EXTREME JOINT PAIN, EXTREME LETHARGY, INABILITY TO SLEEP, HAIRS HAS BEEN THINNING, BODY ODOR, DRY MOUTH/EYES, UNEXPLAINED HIVES, RASHES, INFLAMMATION¿ WERE ADDED. REPORTER WAS ADDED. FOLLOW UP 4 AND 5 PROCESSED TOGETHER. ON 27-JAN-2020: INFORMATION RECEIVED VIA SOCIAL MEDIA. EVENT" AUTOIMMUNE DISORDER WAS UPDATED TO "CONNECTIVE TISSUE DISORDER". A TECHNICAL INVESTIGATION WILL BE 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 PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RASH ("RASH"), WEIGHT INCREASED ("WEIGHT GAIN") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY TO REMOVE ESSURE IMPLANT ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, RASH, WEIGHT INCREASED AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED FATIGUE, PELVIC PAIN, RASH AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: SHE HAD NEED FOR ADDITIONAL SURGERY 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 |
|---|---|---|---|---|---|---|---|
| 835680 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 509813 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other| R | ACYCLOVIR [ACICLOVIR]| ACYCLOVIR [ACICLOVIR]| ACYCLOVIR [ACICLOVIR]| ACYCLOVIR [ACICLOVIR]| FOCALIN| FOCALIN| FOCALIN| HERBAL DIURETIC| HERBAL DIURETIC| HERBAL DIURETIC| HERBAL DIURETICS, OTHER| OTHER THERAPEUTIC PRODUCTS| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN |