BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6386850 · Received March 8, 2017

    Report

    Report Number
    2951250-2017-00783
    Event Type
    Injury
    Date Received
    March 8, 2017
    Date of Event
    September 5, 2014
    Report Date
    May 10, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS REPORTED VIA REGULATORY AUTHORITY ASNM (REFERENCE NUMBER: (B)(4)) ON 10-FEB-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A GENERAL PRACTITIONER AND DESCRIBES THE OCCURRENCE OF RASH ("RASH ON FACE AND NECK") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C13144) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED RASH (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("INCREASE IN NUMBER OF MIGRAINE EPISODES"), NEURALGIA ("INCREASE IN NUMBER OF NEURALGIC HEADACHES"), OEDEMA PERIPHERAL ("OEDEMA OF TOES") AND NAUSEA ("NAUSEA"). THE PATIENT IS PLANNING TO REMOVE ESSURE. AT THE TIME OF THE REPORT, THE RASH, MIGRAINE, NEURALGIA, OEDEMA PERIPHERAL AND NAUSEA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR MIGRAINE, NAUSEA, NEURALGIA, OEDEMA PERIPHERAL AND RASH WITH ESSURE. THE REPORTER COMMENTED: PATIENT KNOWN TO BE PRONE TO MIGRAINE. PATIENT REQUEST FOR ALLERGY TESTS AND FOR CONSULTATION WITH GYNAECOLOGIST TO PLAN REMOVAL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-APR-2017: LOT NUMBER WAS CORRECTED TO C13144 BY REPORTER (PREVIOUSLY REPORTED AS C131144). COMPANY CAUSALITY COMMENT: A FEMALE PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED RASH ON FACE AND NECK. CONSUMER IS PLANNING TO REMOVE ESSURE. THE EVENT IS ANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. THE ESSURE INSERT CONSISTS OF A NICKEL-TITANIUM ALLOY. ALLERGIC REACTIONS TO ESSURE ARE MORE COMMONLY RELATED TO NICKEL SENSITIVITY AND ITS MANIFESTATIONS INCLUDE SKIN ITCHING, RASH, ECZEMATOUS DERMATITIS, AND HIVES THAT RESOLVE AFTER DEVICE REMOVAL. BASED ON ITS NATURE AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT BECAUSE DEVICE REMOVAL WILL BE REQUIRED. ADDITIONALLY, NON-SERIOUS EVENT WAS REPORTED. FURTHER INFORMATION COULD NOT BE OBTAINED. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT.

    Additional Manufacturer Narrative · 1

    THIS CASE WAS REPORTED VIA REGULATORY AUTHORITY (B)(4) ON 10-FEB-2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 04-MAY-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A GENERAL PRACTITIONER AND DESCRIBES THE OCCURRENCE OF RASH ("RASH ON FACE AND NECK") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C13144) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED RASH (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("INCREASE IN NUMBER OF MIGRAINE EPISODES"), NEURALGIA ("INCREASE IN NUMBER OF NEURALGIC HEADACHES"), OEDEMA PERIPHERAL ("OEDEMA OF TOES") AND NAUSEA ("NAUSEA"). THE PATIENT WAS TREATED WITH SURGERY (CONSUMER IS PLANNING TO REMOVE ESSURE). AT THE TIME OF THE REPORT, THE RASH, MIGRAINE, NEURALGIA, OEDEMA PERIPHERAL AND NAUSEA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR MIGRAINE, NAUSEA, NEURALGIA, OEDEMA PERIPHERAL AND RASH WITH ESSURE. THE REPORTER COMMENTED: PATIENT KNOWN TO BE PRONE TO MIGRAINE. PATIENT REQUEST FOR ALLERGY TESTS AND FOR CONSULTATION WITH GYNAECOLOGIST TO PLAN REMOVAL. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDDRA PREFERRED TERM. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 09-MAY-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: RASH. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED (B)(4) CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. QUALITY-SAFETY EVALUATION OF PTC: LOT#: C13144 - PRODUCTION DATE: 20-JAN-2014 - EXPIRATION DATE: 31-JAN-2017. SAMPLE NOT AVAILABLE. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-MAY-2017: QUALITY SAFETY EVALUATION OF PTC. COMPANY CAUSALITY COMMENT: A FEMALE PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED RASH ON FACE AND NECK. CONSUMER IS PLANNING TO REMOVE ESSURE. THE EVENT IS ANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. THE ESSURE INSERT CONSISTS OF A NICKEL-TITANIUM ALLOY. ALLERGIC REACTIONS TO ESSURE ARE MORE COMMONLY RELATED TO NICKEL SENSITIVITY AND ITS MANIFESTATIONS INCLUDE SKIN ITCHING, RASH, ECZEMATOUS DERMATITIS, AND HIVES THAT RESOLVE AFTER DEVICE REMOVAL. BASED ON ITS NATURE AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT BECAUSE DEVICE REMOVAL WILL BE REQUIRED. ADDITIONALLY, NON-SERIOUS EVENT WAS REPORTED. FURTHER INFORMATION COULD NOT BE OBTAINED. ACCORDING TO THE PRODUCT TECHNICAL ANALYSIS, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED VIA REGULATORY AUTHORITY ASNM (REFERENCE NUMBER: (B)(4) ON (B)(6) 2017. THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF RASH ("RASH ON FACE AND NECK") IN A FEMALE PATIENT WHO RECEIVED ESSURE (BATCH NO. C131144). THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT STARTED ESSURE. ON (B)(6) 2014, THE PATIENT EXPERIENCED RASH (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED), MIGRAINE ("INCREASE IN NUMBER OF MIGRAINE EPISODES"), HEADACHE ("INCREASE IN NUMBER OF NEURALGIC HEADACHES"), OEDEMA PERIPHERAL ("OEDEMA OF TOES") AND NAUSEA ("NAUSEA"). CONSUMER IS PLANNING TO REMOVE ESSURE. AT THE TIME OF THE REPORT, THE RASH, MIGRAINE, HEADACHE, OEDEMA PERIPHERAL AND NAUSEA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR RASH, MIGRAINE, HEADACHE, OEDEMA PERIPHERAL AND NAUSEA WITH ESSURE. THE REPORTER COMMENTED: PATIENT KNOWN TO BE PRONE TO MIGRAINE. PATIENT REQUEST FOR ALLERGY TESTS AND FOR CONSULTATION WITH GYNAECOLOGIST TO PLAN REMOVAL. COMPANY CAUSALITY COMMENT: A FEMALE PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED RASH ON FACE AND NECK. CONSUMER IS PLANNING TO REMOVE ESSURE. THE EVENT IS ANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. THE ESSURE INSERT CONSISTS OF A NICKEL-TITANIUM ALLOY. ALLERGIC REACTIONS TO ESSURE ARE MORE COMMONLY RELATED TO NICKEL SENSITIVITY AND ITS MANIFESTATIONS INCLUDE SKIN ITCHING, RASH, ECZEMATOUS DERMATITIS, AND HIVES THAT RESOLVE AFTER DEVICE REMOVAL. BASED ON ITS NATURE AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT BECAUSE DEVICE REMOVAL WILL BE REQUIRED. ADDITIONALLY, NON-SERIOUS EVENT WAS REPORTED. FURTHER INFORMATION AND PRODUCT TECHNICAL ANALYSIS ARE BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169081 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 C13144

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R