ESSURE
Report
- Report Number
- 2951250-2018-01527
- Event Type
- Injury
- Date Received
- April 6, 2018
- Date of Event
- January 1, 2011
- Report Date
- October 28, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('SEVERE ABDOMINAL PAIN') AND ENDOMETRITIS ('ENDOMETRITIS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822375) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MEDROXYPROGESTERONE. CONCURRENT CONDITIONS INCLUDED ANEMIA, MIGRAINE, DEPRESSION AND ANXIETY. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLIN), BUDESONIDE (RHINOCORT AQUA), CETIRIZINE HYDROCHLORIDE, ESCITALOPRAM, ESCITALOPRAM OXALATE (LEXAPRO), ETHINYLESTRADIOL;NORGESTIMATE (SPRINTEC), GLIBENCLAMIDE (GLYBURIDE), LISDEXAMFETAMINE MESILATE (VYVANSE), MONTELUKAST SODIUM (SINGULAIR), PIMECROLIMUS (ELIDEL), VARENICLINE TARTRATE (CHANTIX) AND ZOLPIDEM. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA") AND PELVIC PAIN ("PAIN"). IN (B)(6) 2016, THE PATIENT EXPERIENCED AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("CONCENTRATION ISSUES"), INSOMNIA ("INSOMNIA"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION") AND BLADDER DISORDER ("BLADDER ISSUES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), BACK PAIN ("SEVERE BACK PAIN"), DEPRESSION ("DEPRESSION"), FATIGUE ("FATIGUE"), ABDOMINAL DISTENSION ("BLOATING") AND ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, ENDOMETRITIS, BACK PAIN, DEPRESSION, FATIGUE, ABDOMINAL DISTENSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, AMNESIA, DISTURBANCE IN ATTENTION, INSOMNIA, WEIGHT FLUCTUATION, BLADDER DISORDER AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, DYSMENORRHOEA AND PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, AMNESIA, BACK PAIN, BLADDER DISORDER, DEPRESSION, DISTURBANCE IN ATTENTION, DYSMENORRHOEA, ENDOMETRITIS, FATIGUE, GENITAL HAEMORRHAGE, INSOMNIA, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 157 KGS. THE PUNCTUATE 3-MM LEFTRENAL RELVIS STONE SEEN ON RECENT CT IS NOT VISIBLE ON ABDOMEN X-RAY. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER, LAWYER, LAWYER, CONSUMER OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-OCT-2020: PIF RECEIVED- NEW EVENT CRAMPING WAS ADDED. SERIOUSNESS CRITERIA REMOVED FOR EVENT GENITAL HEMORRHAGE. ON 14-OCT-2020: MR RECEIVED- NO NEW CLINICAL INFORMATION. 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 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 ABDOMINAL PAIN ('SEVERE ABDOMINAL PAIN') AND ENDOMETRITIS ('ENDOMETRITIS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822375) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MEDROXYPROGESTERONE. CONCURRENT CONDITIONS INCLUDED ANEMIA, MIGRAINE, DEPRESSION AND ANXIETY. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLIN), BUDESONIDE (RHINOCORT AQUA), CETIRIZINE HYDROCHLORIDE, ESCITALOPRAM, ESCITALOPRAM OXALATE (LEXAPRO), ETHINYLESTRADIOL;NORGESTIMATE (SPRINTEC), GLIBENCLAMIDE (GLYBURIDE), LISDEXAMFETAMINE MESILATE (VYVANSE), MONTELUKAST SODIUM (SINGULAIR), PIMECROLIMUS (ELIDEL), VARENICLINE TARTRATE (CHANTIX) AND ZOLPIDEM. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA") AND PELVIC PAIN ("PAIN"). IN (B)(6) 2016, THE PATIENT EXPERIENCED AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("CONCENTRATION ISSUES"), INSOMNIA ("INSOMNIA"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION") AND BLADDER DISORDER ("BLADDER ISSUES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), BACK PAIN ("SEVERE BACK PAIN"), DEPRESSION ("DEPRESSION"), FATIGUE ("FATIGUE"), ABDOMINAL DISTENSION ("BLOATING") AND ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, ENDOMETRITIS, BACK PAIN, DEPRESSION, FATIGUE, ABDOMINAL DISTENSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, AMNESIA, DISTURBANCE IN ATTENTION, INSOMNIA, WEIGHT FLUCTUATION, BLADDER DISORDER AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, DYSMENORRHOEA AND PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, AMNESIA, BACK PAIN, BLADDER DISORDER, DEPRESSION, DISTURBANCE IN ATTENTION, DYSMENORRHOEA, ENDOMETRITIS, FATIGUE, GENITAL HAEMORRHAGE, INSOMNIA, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 157 KGS. THE PUNCTUATE 3-MM LEFTRENAL RELVIS STONE SEEN ON RECENT CT IS NOT VISIBLE ON ABDOMEN X-RAY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER, LAWYER, LAWYER, CONSUMER OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-OCT-2020: QUALITY SAFETY EVALUATION OF PTC. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), ENDOMETRITIS ("ENDOMETRITIS") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822375) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ANEMIA, MIGRAINE, DEPRESSION AND ANXIETY. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLIN), BUDESONIDE (RHINOCORT AQUA), CETIRIZINE HYDROCHLORIDE (ZYRTEC), CILEST (SPRINTEC), ESCITALOPRAM, ESCITALOPRAM OXALATE (LEXAPRO), GLIBENCLAMIDE (GLYBURIDE), LISDEXAMFETAMINE MESILATE (VYVANSE), MONTELUKAST (SINGULAIR), PIMECROLIMUS (ELIDEL), VARENICLINE TARTRATE (CHANTIX) AND ZOLPIDEM. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), BACK PAIN ("SEVERE BACK PAIN"), DEPRESSION ("DEPRESSION"), FATIGUE ("FATIGUE"), ABDOMINAL DISTENSION ("BLOATING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), PELVIC PAIN ("PAIN"), AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("CONCENTRATION ISSUES"), INSOMNIA ("INSOMNIA"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION") AND BLADDER DISORDER ("BLADDER ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, ENDOMETRITIS, BACK PAIN, DEPRESSION, FATIGUE, ABDOMINAL DISTENSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, AMNESIA, DISTURBANCE IN ATTENTION, INSOMNIA, WEIGHT FLUCTUATION AND BLADDER DISORDER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, DYSMENORRHOEA AND PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, AMNESIA, BACK PAIN, BLADDER DISORDER, DEPRESSION, DISTURBANCE IN ATTENTION, DYSMENORRHOEA, ENDOMETRITIS, FATIGUE, GENITAL HAEMORRHAGE, INSOMNIA, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 157 KGS. THE PUNCTUATE 3-MM LEFTRENAL RELVIS STONE SEEN ON RECENT CT IS NOT VISIBLE ON ABDOMEN X-RAY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER, LAWYER, LAWYER, CONSUMER OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY SAFETY EVALUATION OF PTC. 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 ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), ENDOMETRITIS ("ENDOMETRITIS") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822375) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ANEMIA, MIGRAINE, DEPRESSION AND ANXIETY. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE), BUDESONIDE (RHINOCORT AQUA), CETIRIZINE HYDROCHLORIDE (ZYRTEC), CILEST (SPRINTEC), ESCITALOPRAM, ESCITALOPRAM OXALATE (LEXAPRO), GLIBENCLAMIDE (GLYBURIDE), LISDEXAMFETAMINE MESILATE (VYVANSE), MONTELUKAST (SINGULAIR), PIMECROLIMUS (ELIDEL), VARENICLINE TARTRATE (CHANTIX) AND ZOLPIDEM. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), BACK PAIN ("SEVERE BACK PAIN"), DEPRESSION ("DEPRESSION"), FATIGUE ("FATIGUE"), ABDOMINAL DISTENSION ("BLOATING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), PELVIC PAIN ("PAIN"), AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("CONCENTRATION ISSUES"), INSOMNIA ("INSOMNIA"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION") AND BLADDER DISORDER ("BLADDER ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, ENDOMETRITIS, BACK PAIN, DEPRESSION, FATIGUE, ABDOMINAL DISTENSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, AMNESIA, DISTURBANCE IN ATTENTION, INSOMNIA, WEIGHT FLUCTUATION AND BLADDER DISORDER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, DYSMENORRHOEA AND PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, AMNESIA, BACK PAIN, BLADDER DISORDER, DEPRESSION, DISTURBANCE IN ATTENTION, DYSMENORRHOEA, ENDOMETRITIS, FATIGUE, GENITAL HAEMORRHAGE, INSOMNIA, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 157 KGS. THE PUNCTUATE 3-MM LEFT RENAL RELVIS STONE SEEN ON RECENT CT IS NOT VISIBLE ON ABDOMEN X-RAY. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER, LAWYER, LAWYER, CONSUMER OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET-ALL RELEVANT MEDICAL HISTORY, CONCURRENT CONDITION, CONCOMITANT MEDICATION AND EVENTS ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA, ENDOMETRITIS, PAIN, SIDE EFFECTS FROM HYSTERECTOMY INCLUDING BUT NOT LIMITED TO MEMORY LOSS, CONCENTRATION ISSUES, INSOMNIA, WEIGHT FLUCTUATION, BLADDER ISSUES ADDED. LOT NUMBER 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 ("SEVERE ABDOMINAL PAIN") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), BACK PAIN ("SEVERE BACK PAIN"), DEPRESSION ("DEPRESSION"), FATIGUE ("FATIGUE") AND ABDOMINAL DISTENSION ("BLOATING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, BACK PAIN, DEPRESSION, FATIGUE AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, BACK PAIN, DEPRESSION, DYSMENORRHOEA, FATIGUE AND GENITAL HAEMORRHAGE TO BE RELATED TO ESSURE. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER, LAWYER OR LAWYER IS NOT POSSIBLE. 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 |
|---|---|---|---|---|---|---|---|
| 245219 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822375 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other| R | ALPRAZOLAM| ALPRAZOLAM| ALPRAZOLAM| ALPRAZOLAM| AMITRIPTYLIN| AMITRIPTYLIN| AMITRIPTYLIN| AMITRIPTYLIN| CETIRIZINE HYDROCHLORIDE| CETIRIZINE HYDROCHLORIDE| CHANTIX| CHANTIX| CHANTIX| CHANTIX| ELIDEL| ELIDEL| ELIDEL| ELIDEL| ESCITALOPRAM| ESCITALOPRAM| ESCITALOPRAM| ESCITALOPRAM| GLYBURIDE| GLYBURIDE| GLYBURIDE| GLYBURIDE| LEXAPRO| LEXAPRO| LEXAPRO| LEXAPRO| RHINOCORT AQUA| RHINOCORT AQUA| RHINOCORT AQUA| RHINOCORT AQUA| SINGULAIR| SINGULAIR| SINGULAIR| SINGULAIR| SPRINTEC| SPRINTEC| SPRINTEC| SPRINTEC| VYVANSE| VYVANSE| VYVANSE| VYVANSE| ZOLPIDEM| ZOLPIDEM| ZOLPIDEM| ZOLPIDEM| ZYRTEC| ZYRTEC |