BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3955103 · Received July 10, 2014

    Report

    Report Number
    2951250-2014-00274
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    January 1, 2009
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP INFORMATION RECEIVED ON (B)(4) 2014: (B)(4). PTC INVESTIGATION RESULT WAS RECEIVED ON(B)(4) 2014. THIS ADVERSE EVENT REPORT IS RELATED TO (B)(4). FINAL ASSESSMENT: 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 CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE 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 AT THIS TIME. MEDICAL ASSESSMENT: THE MEDICAL EVENTS REPORTED ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. NO BATCH NUMBER WAS REPORTED. NEITHER A TECHNICAL BATCH INVESTIGATION NOR A BATCH CLUSTER REVIEW IN THE (B)(4) DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE WITHOUT A BATCH NUMBER. AT THE TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT.

    Additional Manufacturer Narrative · 1

    DATA CORRECTION: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER VIA (B)(4) IN UNITED STATES ON (B)(4) 2014 WHICH REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) AND EXPERIENCED THE FOLLOWING EVENTS. ON (B)(6) 2009, ESSURE WAS INSERTED FOR CONTRACEPTION. CONSUMER REPORTED THAT AFTER THE IMPLANT OF ESSURE SHE STARTED TO EXPERIENCE ENORMOUS AMOUNTS OF INFLAMMATION, WHICH CAUSED EXTREME PAIN. SHE COMPLAINED TO HER PHYSICIAN NUMEROUS TIMES AND SHE PUT HER ON NON-INFLAMMATORY. THE PAIN CONTINUED THE WHOLE TIME HAD THE ESSURE INSIDE HER. THEN, SHE REPORTED, THAT SHE STARTED HAVING HUGE CYSTS ON HER OVARIES; SHE WAS DIAGNOSED BY ULTRASOUND. SHE WENT TO THE EMERGENCY ROOM FOR THE EXTREME PAIN OF CYST ON HER OVARY. ON (B)(6) 2011, SHE UNDERWENT A SURGERY TO REMOVE THE DEVICES; SHE ONLY KNEW THAT THEY WOULD REMOVE HER WHOLE TUBES OUT A LITTLE BEFORE THE SURGERY. CONSUMER STATED THAT PREVENTING HER FROM BEING A MOTHER AGAIN CRUSHED HER DREAMS AND HOPES AND LEFT HER FEELING LESS OF A WOMAN. CONSUMER ALSO STATED THAT SHE NEVER HAD THESE PROBLEMS BEFORE. SHE WAS DIAGNOSED WITH FIBROMYALGIA AND HAD TO DEAL WITH LEEP PROCEDURES SINCE ESSURE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404572 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other