BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5220656 · Received November 12, 2015

    Report

    Report Number
    2951250-2015-01441
    Event Type
    Injury
    Date Received
    November 12, 2015
    Date of Event
    July 1, 2011
    Report Date
    January 20, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT AND ASSESSMENT OF THE PRODUCT TECHNICAL COMPLAINT INVESTIGATION RECEIVED ON 06-NOV-2015: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: (B)(4). FINAL ASSESSMENT: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: NO PRODUCT QUALITY DEFECT WAS CONFIRMED THEREFORE A RELATIONSHIP TO THE REPORTED MEDICAL EVENT(S) IS EXCLUDED. THE REPORTED MEDICAL EVENT(S) ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENT(S) AND A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED ABNORMAL PERIODS AND HEADACHES. ACCORDING TO HER, SHE WAS HAVING HER TUBES AND PART OF HER UTERUS REMOVED IN 10 DAYS (FOLLOWING THIS REPORT). THESE EVENTS ARE LISTED ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION ABNORMAL GENITAL BLEEDING AND MENSES PATTERN CHANGES MAY OCCUR. IN THIS CASE, LIMITED INFORMATION WAS PROVIDED. NEVERTHELESS, CONSIDERING ABNORMAL PERIODS NATURE; CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. REGARDING THE REPORTED HEADACHES; ALTHOUGH ESSURE HAS ONLY A LOCAL ACTION IN FALLOPIAN TUBES; CONSUMER STATED THIS EVENT STARTED IMMEDIATELY AFTER DEVICE INSERTION AND NO ALTERNATIVE EXPLANATION WAS FOUND (SHE CONSULTED NEUROLOGISTS AND HAD MRI, CT). THUS; CAUSALITY WITH THE SUSPECT INSERT CANNOT BE TOTALLY RULED OUT. IN ADDITION NON-SERIOUS EVENTS WERE REPORTED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WILL BE REQUIRED (INTERVENTION IS SCHEDULED). THE PRODUCT TECHNICAL ANALYSIS CONCLUDED THAT BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT. NO ACTIVE FOLLOW-UP WILL BE PURSUED (CASE WAS IDENTIFIED DURING HEALTH AUTHORITY WEBSITE MONITORING).

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    THIS CASE HAS BEEN IDENTIFIED DURING MONITORING OF POSTINGS ON AN FDA HOSTED DOCKET WEBSITE, WHICH HAS BEEN ESTABLISHED IN PREPARATION OF A PUBLIC FDA ADVISORY COMMITTEE MEETING, WHICH TOOK PLACE IN SEPTEMBER 2015 (FDA-2014-N-0736-1926, AWARENESS DATE 19-OCT-2015). IT REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE IN UNITED STATES WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN (B)(6) 2011. CONSUMER REPORTED THAT IMMEDIATELY AFTER INSERTION SHE STARTED TO HAVE HEADACHES, BUT NOT NORMAL HEADACHES, ONES THAT SENT HER TO THE HOSPITAL IN NUMEROUS OCCASION AND HER EYES WOULD BLUR OVER AND IT FELT LIKE SOMEONE WAS STABBING HER. SHE WENT TO NEUROLOGISTS, HAD MAGNETIC RESONANCE IMAGING, COMPUTED TOMAGRAPHIES AND NO ONE COULD TELL WHAT WAS WRONG WITH HER. SHE ALSO HAD ABNORMAL PERIODS, CONSTANTLY BLOATED REGARDLESS OF WHAT SHE DID OR EAT, VITAM D DEFICIENCY, HER HORMONAL LEVELS WERE NOT NORMAL AND SHE HAD AN OBSCENE AMOUNT OF VAGINAL INFECTIONS - BACTERIAL VAGINOSIS, MULTIPLE TIMES A YEAR. SHE WAS HAVING HER TUBES AND PART OF HER UTERUS REMOVED IN (B)(6) 2015. COMPANY CAUSALITY COMMENT THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED ABNORMAL PERIODS AND HEADACHES. ACCORDING TO HER, SHE WAS HAVING HER TUBES AND PART OF HER UTERUS REMOVED IN 10 DAYS (FOLLOWING THIS REPORT). THESE EVENTS ARE LISTED ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION ABNORMAL GENITAL BLEEDING AND MENSES PATTERN CHANGES MAY OCCUR. IN THIS CASE, LIMITED INFORMATION WAS PROVIDED. NEVERTHELESS, CONSIDERING ABNORMAL PERIODS NATURE; CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. REGARDING THE REPORTED HEADACHES; ALTHOUGH ESSURE HAS ONLY A LOCAL ACTION IN FALLOPIAN TUBES; CONSUMER STATED THIS EVENT STARTED IMMEDIATELY AFTER DEVICE INSERTION AND NO ALTERNATIVE EXPLANATION WAS FOUND (SHE CONSULTED NEUROLOGISTS AND HAD MRI, CT). THUS; CAUSALITY WITH THE SUSPECT INSERT CANNOT BE TOTALLY RULED OUT. IN ADDITION NON-SERIOUS EVENTS WERE REPORTED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WILL BE REQUIRED (INTERVENTION IS SCHEDULED). A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT. NO ACTIVE FOLLOW-UP WILL BE PURSUED (CASE WAS IDENTIFIED DURING HEALTH AUTHORITY WEBSITE MONITORING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750505 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other