BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7116764 · Received December 14, 2017

    Report

    Report Number
    2951250-2017-10747
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    July 1, 2004
    Report Date
    August 8, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5038353) ON (B)(6) 2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 23-JUL-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PAIN/EXTREME PAIN ON MY LEFT SIDE PELVIS/ SHARP PERSISTENT PAINS IN MY LEFT SIDE SPORADICALLY/ PELVIC PAIN"), CERVIX CARCINOMA ("11 YEARS LATER CERVICAL CANCER/CERVICAL CANCER"), THE FIRST EPISODE OF MULTIPLE SCLEROSIS RELAPSE ("EXACERBATED PREEXISTING MS TO WHEELCHAIR 24/7 / DISEASE PROGRESSED/WORSENED MULTIPLE SCLEROSIS/MY MEDICINE THAT WAS FENDING OFF MY MS ATTACKS NO LONGER SEEMED TO WORK"), THE SECOND EPISODE OF MULTIPLE SCLEROSIS RELAPSE ("MS FLARE AFTER HYSTO"), LOSS OF CONSCIOUSNESS ("I BEGAN PASSING OUT FROM THE MS SHOTS") AND GENITAL HAEMORRHAGE ("BLEEDING SEVERELY") IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, LIVE BIRTH IN 1999 AND LIVE BIRTH ON (B)(6) 2003. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: AVONEX. CONCURRENT CONDITIONS INCLUDED MULTIPLE SCLEROSIS SINCE 1997, CANE USER, WHEELCHAIR USER, CERVICAL DYSPLASIA, HAY FEVER, FATIGUE, VISION ABNORMAL, RASH, ANXIETY, PULMONARY STENOSIS, FUNGAL DERMATITIS AND PARATUBAL CYST. CONCOMITANT PRODUCTS INCLUDED INTERFERON BETA-1A (REBIF) FOR MULTIPLE SCLEROSIS, INTERFERON BETA-1A (AVONEX) FOR PROGRESSION OF MULTIPLE SCLEROSIS AS WELL AS COLECALCIFEROL (VITAMIN D), FUROSEMIDE SINCE 2004 AND GABAPENTIN. ON (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2004, THE PATIENT EXPERIENCED GAIT DISTURBANCE ("DIFFICULTY WALKING/ I CONTINUE TO HAVE DIFFICULTY WALKING"), LACRIMATION INCREASED ("RUNNING, WATERY EYES") AND PALPITATIONS ("HEART PALPITATIONS"). IN (B)(6) 2004, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF MULTIPLE SCLEROSIS RELAPSE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH DYSSTASIA, POLYCYSTIC OVARIES ("LEFT OVARY FULL OF BENIGN CYSTS/OVARIAN CYSTS"), WEIGHT INCREASED ("WEIGHT GAIN/RAPID WEIGHT GAIN, LOST ABOUT A HUNDRED POUNDS WITHIN SIX MONTHS AFTER REMOVAL"), MENORRHAGIA ("VERY HEAVY MENSTRUAL FLOW, HEAVY PERIODS") AND ARTHRALGIA ("HIP PAIN ON THE LEFT SIDE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2015, 11 YEARS 1 MONTH AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED THE SECOND EPISODE OF MULTIPLE SCLEROSIS RELAPSE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL REGION PAIN / CRAMPING"), ABDOMINAL DISTENSION ("SEVERE BLOATING"), TENDONITIS ("HAVE SEVERE TENDINITIS IN MY LEFT HAND"), SEXUAL DYSFUNCTION ("UNABLE TO HAVE SEXUAL RELATIONS WITH MY HUSBAND"), DEVICE ALLERGY ("PET HYPERSENSITIVITY/FOREIGN BODY RESPONSE/ALLERGIC TO ANY OTHER COMPONENT OF ESSURE HYPERSENSITIVITY REACTION TO ANY OTHER COMPONENT OF ESSURE") WITH SNEEZING AND PRURITUS, ALLERGY TO METALS ("LONG TERM LONG TERM NICKEL EXPOSURE IS TOXIC/ALLERGIC TO NICKEL / HYPERSENSITIVITY REACTION TO NICKEL") WITH PRURITUS AND SNEEZING, MENTAL DISORDER ("ESSURE CAUSED OR AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITIONS"), EYE PRURITUS ("ITCHY EYES"), ABDOMINAL PAIN LOWER ("CRAMPING") AND VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING"). THE PATIENT WAS TREATED WITH DIMETHYL FUMARATE (TECFIDERA), PANADEINE CO (TYLENOL WITH CODEINE), GLATIRAMER ACETATE (COPAXONE), OXYCOCET (PERCOCET), SURGERY (ROBOTIC ASSISTED LAPAROSCOPIC TOTAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY) AND SURGERY. ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, POLYCYSTIC OVARIES, WEIGHT INCREASED, LACRIMATION INCREASED, PALPITATIONS, EYE PRURITUS, ABDOMINAL PAIN LOWER AND VAGINAL HAEMORRHAGE HAD RESOLVED, THE CERVIX CARCINOMA, THE LAST EPISODE OF MULTIPLE SCLEROSIS RELAPSE, LOSS OF CONSCIOUSNESS, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, ABDOMINAL DISTENSION, MENORRHAGIA, GAIT DISTURBANCE, TENDONITIS, ARTHRALGIA, SEXUAL DYSFUNCTION AND MENTAL DISORDER OUTCOME WAS UNKNOWN AND THE DEVICE ALLERGY AND ALLERGY TO METALS WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ARTHRALGIA, CERVIX CARCINOMA, DEVICE ALLERGY, EYE PRURITUS, GAIT DISTURBANCE, GENITAL HAEMORRHAGE, LACRIMATION INCREASED, LOSS OF CONSCIOUSNESS, LOSS OF PERSONAL MENORRHAGIA, MENTAL DISORDER, PALPITATIONS, PELVIC PAIN, POLYCYSTIC OVARIES, SEXUAL DYSFUNCTION, TENDONITIS, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF MULTIPLE SCLEROSIS RELAPSE AND THE SECOND EPISODE OF MULTIPLE SCLEROSIS RELAPSE TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 38.3 KG/SQM. ULTRASOUND SCAN - ON AN UNKNOWN DATE: LEFT OVARY FULL OF BENIGN CYSTS IN (B)(6) 2004, SHE UNDERWENT HYSTEROSALPINGOGRAM FOR ESSURE PLACEMENT CONFIRMATION. IN (B)(6) 2007, SHE UNDERWENT CYSTOSCOPY WAS DONE. ON(B)(6) 2017, SHE UNDERWENT SUPRA PUBIC CATHETER. IN 1998, SHE UNDERWENT MULTIPLE MRI. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: PELVIC PAIN, CERVIX CARCINOMA, MULTIPLE SCLEROSIS RELAPSE QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT: CASE UPGRADED TO INCIDENT. SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. CERVICAL CANCER AND MS, AS REPORTED BY THE SUBJECT IN THE SOCIAL MEDIA TWEET, ARE NOT KNOWN FAILURE MODES RELATED TO ESSURE. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE REPORTED ADVERSE EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE AND ARE CONSIDERED UNRELATED TO THE PRODUCT BY COMPANY. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NEITHER BATCH NUMBER NOR COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS AND MR RECEIVED: NEW REPORTERS, PATIENT DEMOGRAPHIC INFORMATION, PRODUCT INDICATION UPDATED, CONCOMITANT DISEASE AND MEDICATIONS, NEW EVENTS EYE PRURITUS, ABDOMINAL PAIN LOWER AND VAGINAL HAEMORRHAGE ADDED. OUTCOME FOR THE EVENTS PELVIC PAIN, EYE PRURITUS, LACRIMATION INCREASED, PALPITATIONS, POLYCYSTIC OVARIES, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED UPDATED TO RECOVERED / RESOLVED. 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.

    Description of Event or Problem · 1

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY FOOD AND DRUG ADMINISTRATION (REFERENCE NUMBER: MW5038353). THE MOST RECENT INFORMATION WAS RECEIVED ON 16-NOV-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PAIN/EXTREME PAIN ON MY LEFT SIDE PELVIS/ SHARP PERSISTENT PAINS IN MY LEFT SIDE SPORADICALLY/ PELVIC PAIN"), CERVIX CARCINOMA ("11 YEARS LATER CERVICAL CANCER/CERVICAL CANCER"), THE FIRST EPISODE OF MULTIPLE SCLEROSIS RELAPSE ("EXACERBATED PREEXISTING MS TO WHEELCHAIR 24/7 / DISEASE PROGRESSED/WORSENED MULTIPLE SCLEROSIS/MY MEDICINE THAT WAS FENDING OFF MY MS ATTACKS NO LONGER SEEMED TO WORK"), THE SECOND EPISODE OF MULTIPLE SCLEROSIS RELAPSE ("MS FLARE AFTER HYSTO"), LOSS OF CONSCIOUSNESS ("I BEGAN PASSING OUT FROM THE MS SHOTS") AND GENITAL HAEMORRHAGE ("BLEEDING SEVERELY") IN A (B)(6) OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, LIVE BIRTH IN 1999 AND LIVE BIRTH ON (B)(6) 2003. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: AVONEX. CONCURRENT CONDITIONS INCLUDED MULTIPLE SCLEROSIS SINCE 1997, CANE USER AND WHEELCHAIR USER. CONCOMITANT PRODUCTS INCLUDED INTERFERON BETA-1A (AVONEX) AND INTERFERON BETA-1A (REBIF) FOR MULTIPLE SCLEROSIS. ON (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2004, THE PATIENT EXPERIENCED GAIT DISTURBANCE ("DIFFICULTY WALKING/ I CONTINUE TO HAVE DIFFICULTY WALKING"), LACRIMATION INCREASED ("WATERY EYES") AND PALPITATIONS ("HEART PALPITATIONS"). IN (B)(6) 2004, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF MULTIPLE SCLEROSIS RELAPSE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH DYSSTASIA, POLYCYSTIC OVARIES ("LEFT OVARY FULL OF BENIGN CYSTS/OVARIAN CYSTS"), WEIGHT INCREASED ("WEIGHT GAIN/RAPID WEIGHT GAIN"), MENORRHAGIA ("VERY HEAVY MENSTRUAL FLOW") AND ARTHRALGIA ("HIP PAIN ON THE LEFT SIDE"). ON (B)(6) 2015, 11 YEARS 1 MONTH AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED THE SECOND EPISODE OF MULTIPLE SCLEROSIS RELAPSE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), LOSS OF CONSCIOUSNESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL REGION PAIN / CRAMPING"), ABDOMINAL DISTENSION ("SEVERE BLOATING"), TENDONITIS ("HAVE SEVERE TENDINITIS IN MY LEFT HAND"), SEXUAL DYSFUNCTION ("UNABLE TO HAVE SEXUAL RELATIONS WITH MY HUSBAND"), DEVICE ALLERGY ("PET HYPERSENSITIVITY/FOREIGN BODY RESPONSE/ALLERGIC TO ANY OTHER COMPONENT OF ESSURE HYPERSENSITIVITY REACTION TO ANY OTHER COMPONENT OF ESSURE") WITH SNEEZING AND PRURITUS, ALLERGY TO METALS ("LONG TERM LONG TERM NICKEL EXPOSURE IS TOXIC/ALLERGIC TO NICKEL / HYPERSENSITIVITY REACTION TO NICKEL") WITH PRURITUS AND SNEEZING AND MENTAL DISORDER ("ESSURE CAUSED OR AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITIONS"). THE PATIENT WAS TREATED WITH DIMETHYL FUMARATE (TECFIDERA), PANADEINE CO (TYLENOL WITH CODEINE), GLATIRAMER ACETATE (COPAXONE), SURGERY (HYSTERECTOMY WAS DONE) AND SURGERY. ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, CERVIX CARCINOMA, THE LAST EPISODE OF MULTIPLE SCLEROSIS RELAPSE, LOSS OF CONSCIOUSNESS, GENITAL HAEMORRHAGE, POLYCYSTIC OVARIES, ABDOMINAL PAIN, ABDOMINAL DISTENSION, WEIGHT INCREASED, MENORRHAGIA, GAIT DISTURBANCE, LACRIMATION INCREASED, TENDONITIS, ARTHRALGIA, SEXUAL DYSFUNCTION AND MENTAL DISORDER OUTCOME WAS UNKNOWN AND THE PALPITATIONS, DEVICE ALLERGY AND ALLERGY TO METALS WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ARTHRALGIA, CERVIX CARCINOMA, DEVICE ALLERGY, GAIT DISTURBANCE, GENITAL HAEMORRHAGE, LACRIMATION INCREASED, LOSS OF CONSCIOUSNESS, MENORRHAGIA, MENTAL DISORDER, PALPITATIONS, PELVIC PAIN, POLYCYSTIC OVARIES, SEXUAL DYSFUNCTION, TENDONITIS, WEIGHT INCREASED, THE FIRST EPISODE OF MULTIPLE SCLEROSIS RELAPSE AND THE SECOND EPISODE OF MULTIPLE SCLEROSIS RELAPSE TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 38.3 KG/SQM. ULTRASOUND SCAN - ON AN UNKNOWN DATE: LEFT OVARY FULL OF BENIGN CYSTS IN (B)(6) 2004, SHE UNDERWENT HYSTEROSALPINGOGRAM FOR ESSURE PLACEMENT CONFIRMATION. IN (B)(6) 2007, SHE UNDERWENT CYSTOSCOPY WAS DONE. ON (B)(6) 2017, SHE UNDERWENT SUPRA PUBIC CATHETER. IN 1998, SHE UNDERWENT MULTIPLE MRI. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT: CASE UPGRADED TO INCIDENT. SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. CERVICAL CANCER AND MS, AS REPORTED BY THE SUBJECT IN THE SOCIAL MEDIA TWEET, ARE NOT KNOWN FAILURE MODES RELATED TO ESSURE. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE REPORTED ADVERSE EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE AND ARE CONSIDERED UNRELATED TO THE PRODUCT BY COMPANY. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NEITHER BATCH NUMBER NOR COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: HYSTERECTOMY WAS PERFORMED ON (B)(6) 2014, CASE UPGRADED TO INCIDENT. PREVIOUSLY REPORTED ¿PAIN¿ WAS UPDATED TO PELVIC PAIN. EVENTS MS RELAPSE, DEVICE ALLERGY, POLYCYSTIC OVARIES, ABDOMINAL PAIN, WEIGHT GAIN WERE UPDATED. EVENTS ADDED- NICKEL ALLERGY, HEAVY MENSTRUAL FLOW, DIFFICULTY WALKING, WATERY EYES, HEART PALPITATIONS, BEGAN PASSING OUT FROM THE MS SHOTS, SEVERE TENDINITIS IN LEFT HAND, HIP PAIN, UNABLE TO HAVE SEXUAL RELATIONS WITH MY HUSBAND AND ESSURE CAUSED OR AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITIONS. HISTORICAL CONDITIONS, CONCOMITANT DRUGS, TREATMENT DRUGS AND LAB DATA ADDED. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER PHARMA (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. 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
    898550 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R AVONEX.| AVONEX.| FUROSEMIDE.| GABAPENTIN.| REBIF.| REBIF.| VITAMIN D.| AVONEX| REBIF