BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7372659 · Received March 27, 2018

    Report

    Report Number
    2951250-2018-01272
    Event Type
    Injury
    Date Received
    March 27, 2018
    Date of Event
    April 1, 2012
    Report Date
    October 29, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION'), FALLOPIAN TUBE PERFORATION ('PERFORATION: FALLOPIAN TUBES'), PELVIC PAIN ('PELVIC PAIN / CHRONIC'), GENITAL HAEMORRHAGE ('EXCESSIVE AND ABNORMAL BLEEDING/GENERAL ABNORMAL BLEEDING') AND AXILLARY MASS ('SURGERY: LUMP UNDER LEFT ARMPIT') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 886675 (L), 922602 (R)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PNEUMONIA IN 2007, POST-TRAUMATIC STRESS DISORDER (HOSPITALIZATION) IN 2006, HEART ATTACK (HOSPITALIZATION) IN 2006, SINUS TACHYCARDIA IN 2006, CARDIAC ARRHYTHMIA IN 2006, GENITAL BLEEDING, VAGINAL BLEEDING, MENORRHAGIA, WEIGHT GAIN, FATIGUE, ANXIETY, PULMONARY EMBOLISM (HOSPITALIZATION, DOPPLER), HYPERTENSION AND HEMATURIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR ANXIETY: CYMBALTA IN 2007; FOR BIRTH CONTROL: YASMIN FROM 2005 TO 2006 AND MIRENA FROM 2006 TO NOVEMBER 2011; FOR PE: HEPARIN IN 2006 AND COUMADIN; FOR AN UNREPORTED INDICATION: SERTRALINE FROM (B)(6) 2010 TO (B)(6) 2017 AND WARFARIN SODIUM IN 2006. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED PULMONARY EMBOLISM WITH YASMIN. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE;NALTREXONE HYDROCHLORIDE (CONTRAVE) FROM (B)(6) 2017 TO (B)(6) 2018, DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) FROM (B)(6) 2016 TO (B)(6) 2017, FEXOFENADINE FROM (B)(6) 2017 TO (B)(6) 2018, PRAZOSIN FROM (B)(6) 2017 TO (B)(6) 2017 AND TOPIRAMATE FROM (B)(6) 2018 TO (B)(6) 2018. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), PAIN IN EXTREMITY ("FEET PAIN") AND ARTHRALGIA ("HIP PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY DISORDER ("ANXIETY DISORDER") AND PANIC ATTACK ("PANIC ATTACKS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED RASH ("LEG RASH"). IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPING"), DEPRESSION ("DEPRESSION/PSYCH INJURY"), URINARY TRACT INFECTION ("UTI (URINARY TRACT INFECTION)"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), AXILLARY MASS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PROCEDURAL PAIN ("UNABLE TO PLACE 2ND COIL ON 1ST VISIT DUE TO EXTREME PAIN"). THE PATIENT WAS TREATED WITH ALPRAZOLAM (XANAX), ARIPIPRAZOLE (ABILIFY), CORTISONE ACETATE, ESCITALOPRAM OXALATE (LEXAPRO), IBUPROFEN, TRIAMCINOLONE ACETONIDE, PARACETAMOL + CAFFEINE + PYRILAMINE MALEATE (MIDOL MENSTRUAL COMPLETE FORMULA) AND SURGERY (SHE UNDERWENT HYSTERECTOMY (PARTIAL), SALPINGECTOMY (BILATERAL) REMOVAL OF DEVICE AND SURGERY OF LUMP IN LEFT ARM PIT). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, ABDOMINAL PAIN LOWER, DEPRESSION, ALLERGY TO METALS, URINARY TRACT INFECTION, RASH, MIGRAINE, HEADACHE, AXILLARY MASS, DYSPAREUNIA AND PROCEDURAL PAIN OUTCOME WAS UNKNOWN, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ALOPECIA, FATIGUE, WEIGHT INCREASED, MENORRHAGIA, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, BACK PAIN, PAIN IN EXTREMITY, ARTHRALGIA AND PANIC ATTACK HAD RESOLVED AND THE ANXIETY DISORDER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ANXIETY DISORDER, ARTHRALGIA, AXILLARY MASS, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PAIN IN EXTREMITY, PANIC ATTACK, PELVIC PAIN, PROCEDURAL PAIN, RASH, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER MEDICAL RECORD: ESSURE INSERTION DETAIL: TRAILING COILS OBSERVED WERE RIGHT: 4 COILS AND LEFT: 4 COILS. PER PPF: ESSURE DATE OF INSERTION: (B)(6) 2011 (L) AND (B)(6) 2012 (R). ESSURE REMOVAL DATE: (B)(6) 2017 HYSTERECTOMY (PARTIAL), SALPINGECTOMY (BILATERAL) (NOTE DISCREPANCY). SHE HAD RECEIVED TREATMENT FOR FOLLOWING EVENTS" DYSMENORRHEA, MENORRHAGIA, NICKEL ALLERGY, RASH/SKIN CONDITION, PSYCH INJURY, MIGRATION, FALLOPIAN TUBE PERFORATION, UTI (URINARY TRACT INFECTION), FATIGUE, MIGRAINE, WEIGHT GAIN AND HEADACHES". CURRENT WEIGHT 232 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 97.959 KGS. IMAGING PROCEDURE - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. ULTRASOUND PELVIS - IN (B)(6) 2011: ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA). ULTRASOUND SCAN - ON (B)(6) 2006: OVARIAN CYST. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: MIGRATION, ANXIETY". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-SEP-2019: PLAINTIFF FACT SHEET RECEIVED. EVENTS¿ MIGRATION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), CHRONIC DYSMENORRHEA (CRAMPING), NICKEL ALLERGY, UTI (URINARY TRACT INFECTION), LEG RASH, MIGRAINE AND HEADACHES¿. EVENT¿ GENITAL BLEEDING¿ OUTCOME WAS UPDATED TO RECOVERED/RESOLVED¿. REPORTER INFORMATION, DEMOGRAPHICS, LAB DATA, ESSURE INDICATION (AMENDED) WERE ADDED. ON 20-SEP-2019: NO NEW SIGNIFICANT CLINICAL INFORMATION. ON 20-SEP-2019: REPORTER INFORMATION WAS ADDED. THE CASE IS MEDICALLY CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION'), FALLOPIAN TUBE PERFORATION ('PERFORATION: FALLOPIAN TUBES'), PELVIC PAIN ('PELVIC PAIN / CHRONIC'), GENITAL HAEMORRHAGE ('EXCESSIVE AND ABNORMAL BLEEDING/GENERAL ABNORMAL BLEEDING') AND AXILLARY MASS ('SURGERY: LUMP UNDER LEFT ARMPIT') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 886675 (L), 922602 (R)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PNEUMONIA IN 2007, POST-TRAUMATIC STRESS DISORDER (HOSPITALIZATION) IN 2006, HEART ATTACK (HOSPITALIZATION) IN 2006, SINUS TACHYCARDIA IN 2006, CARDIAC ARRHYTHMIA IN 2006, GENITAL BLEEDING, VAGINAL BLEEDING, MENORRHAGIA, WEIGHT GAIN, FATIGUE, ANXIETY, PULMONARY EMBOLISM (HOSPITALIZATION, DOPPLER), HYPERTENSION AND HEMATURIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR ANXIETY: CYMBALTA IN 2007; FOR BIRTH CONTROL: YASMIN FROM 2005 TO 2006 AND MIRENA FROM 2006 TO NOVEMBER 2011; FOR PE: HEPARIN IN 2006 AND COUMADIN; FOR AN UNREPORTED INDICATION: SERTRALINE FROM (B)(6) 2010 TO (B)(6) 2017 AND WARFARIN SODIUM IN 2006. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED PULMONARY EMBOLISM WITH YASMIN. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE;NALTREXONE HYDROCHLORIDE (CONTRAVE) FROM (B)(6) 2017 TO (B)(6) 2018, DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) FROM (B)(6) 2016 TO (B)(6) 2017, FEXOFENADINE FROM (B)(6) 2017 TO (B)(6) 2018, PRAZOSIN FROM (B)(6) 2017 TO (B)(6) 2017 AND TOPIRAMATE FROM (B)(6) 2018 TO (B)(6) 2018. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), PAIN IN EXTREMITY ("FEET PAIN") AND ARTHRALGIA ("HIP PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY DISORDER ("ANXIETY DISORDER") AND PANIC ATTACK ("PANIC ATTACKS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED RASH ("LEG RASH"). IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPING"), DEPRESSION ("DEPRESSION/PSYCH INJURY"), URINARY TRACT INFECTION ("UTI (URINARY TRACT INFECTION)"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), AXILLARY MASS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PROCEDURAL PAIN ("UNABLE TO PLACE 2ND COIL ON 1ST VISIT DUE TO EXTREME PAIN"). THE PATIENT WAS TREATED WITH ALPRAZOLAM (XANAX), ARIPIPRAZOLE (ABILIFY), CORTISONE ACETATE, ESCITALOPRAM OXALATE (LEXAPRO), IBUPROFEN, TRIAMCINOLONE ACETONIDE, PARACETAMOL + CAFFEINE + PYRILAMINE MALEATE (MIDOL MENSTRUAL COMPLETE FORMULA) AND SURGERY (SHE UNDERWENT HYSTERECTOMY (PARTIAL), SALPINGECTOMY (BILATERAL) REMOVAL OF DEVICE AND SURGERY OF LUMP IN LEFT ARM PIT). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, ABDOMINAL PAIN LOWER, DEPRESSION, ALLERGY TO METALS, URINARY TRACT INFECTION, RASH, MIGRAINE, HEADACHE, AXILLARY MASS, DYSPAREUNIA AND PROCEDURAL PAIN OUTCOME WAS UNKNOWN, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ALOPECIA, FATIGUE, WEIGHT INCREASED, MENORRHAGIA, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, BACK PAIN, PAIN IN EXTREMITY, ARTHRALGIA AND PANIC ATTACK HAD RESOLVED AND THE ANXIETY DISORDER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ANXIETY DISORDER, ARTHRALGIA, AXILLARY MASS, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PAIN IN EXTREMITY, PANIC ATTACK, PELVIC PAIN, PROCEDURAL PAIN, RASH, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER MEDICAL RECORD: ESSURE INSERTION DETAIL: TRAILING COILS OBSERVED WERE RIGHT: 4 COILS AND LEFT: 4 COILS. PER PPF: ESSURE DATE OF INSERTION: (B)(6) 2011 (L) AND (B)(6) 2012 (R). ESSURE REMOVAL DATE: (B)(6) 2017 HYSTERECTOMY (PARTIAL), SALPINGECTOMY (BILATERAL) (NOTE DISCREPANCY). SHE HAD RECEIVED TREATMENT FOR FOLLOWING EVENTS" DYSMENORRHEA, MENORRHAGIA, NICKEL ALLERGY, RASH/SKIN CONDITION, PSYCH INJURY, MIGRATION, FALLOPIAN TUBE PERFORATION, UTI (URINARY TRACT INFECTION), FATIGUE, MIGRAINE, WEIGHT GAIN AND HEADACHES". CURRENT WEIGHT 232 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 97.959 KGS. IMAGING PROCEDURE - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. ULTRASOUND PELVIS - IN (B)(6) 2011: ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA). ULTRASOUND SCAN - ON (B)(6) 2006: OVARIAN CYST. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: MIGRATION, ANXIETY". LOT NUMBER: 886675; MANUFACTURING DATE: 2011/08; EXPIRATION DATE: 2014/08. LOT NUMBER: 922602; MANUFACTURING DATE: 2011/11; EXPIRATION DATE: 2014/11. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-OCT-2019: QUALITY-SAFETY EVALUATION OF PTC. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE AND ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPING"), ALOPECIA ("HAIR LOSS"), ANXIETY ("ANXIETY"), FATIGUE ("FATIGUE"), DEPRESSION ("DEPRESSION") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT SURGICAL REMOVAL OF DEVICE ON (B)(6) 2017). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, FATIGUE, DEPRESSION AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, DEPRESSION, FATIGUE, GENITAL HAEMORRHAGE, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. 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
    218705 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 886675 (L), 922602 (R)

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R CONTRAVE.| CONTRAVE.| DOXYCYCLINE [DOXYCYCLINE MONOHYDRATE].| DOXYCYCLINE [DOXYCYCLINE MONOHYDRATE].| FEXOFENADINE.| FEXOFENADINE.| PRAZOSIN.| PRAZOSIN.| TOPIRAMATE.| TOPIRAMATE.