BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3902243 · Received June 24, 2014

    Report

    Report Number
    2951250-2014-00243
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PTC INVESTIGATION RESULT RECEIVED ON (B)(4) 2014. (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. IN THIS CASE 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 AT THIS TIME. MEDICAL ASSESSMENT: THE MEDICAL EVENTS REPORTED ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. ONE (1) ADDITIONAL AE CASE REPORT HAS BEEN RECEIVED TO DATE IN RELATION TO BATCH NUMBER (B)(4) BUT THIS CASE DOES NOT REFER TO ANY SIMILAR TYPE OF MEDICAL EVENT. NO BATCH SIGNAL COULD BE IDENTIFIED AT THIS TIME. THE REVIEW OF THE LOT HISTORY RECORDS CONFIRMED THAT THE PRODUCT MET PRODUCT RELEASE SPECIFICATIONS. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. 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.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER VIA REGULATORY AUTHORITY (CASE # (B)(4)) IN UNITED STATES ON (B)(4) 2014 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED SHARP PAINS IN LEFT SIDE, HIP PAIN, LOWER BACK PAIN, ABDOMEN PAIN, MIGRAINES, STOMACH PAIN, BURNING SKIN, ITCHY SKIN, RASH, MOOD FLUCTUATIONS, HAIR LOSS, DIZZINESS, AND INSOMNIA. ON (B)(6) 2013 THE CONSUMER HAD ESSURE (FALLOPIAN TUBE INSERT) INSERTED (LOT NUMBER B04950). CONSUMER REPORTED THAT DURING THE IMPLANTATION OF THE DEVICE IN 2013 HER LEFT TUBE DID NOT ACCEPT THE ESSURE COIL AND THE DEVICE WAS NOT IMPLANTED. SHE BEGAN HAVING SHARP PAINS IN HER LEFT SIDE, HIP AND LOWER BACK AND ABDOMEN PAIN. SHE ALSO BEGAN HAVING MIGRAINES, EXTREME STOMACH PAIN, BURNING, ITCHY SKIN AND RASH, EXTREME MOOD FLUCTUATIONS, EXTREME HAIR LOSS, DIZZINESS AND INSOMNIA. CONSUMER WENT TO THE DOCTOR AND THE DOCTOR PERFORMED AN ULTRASOUND WHICH CONFIRMED THE LEFT COIL WAS IN THE RIGHT PLACE AND GAVE HER THE OPTION TO CONSIDER SURGERY BECAUSE IT SEEMED THAT HER BODY WAS REJECTING THE COIL ON (B)(6) 2014, SHE HAD A HYSTERECTOMY BY LAPAROSCOPIC SURGERY. CONSUMER DID NOT PROVIDE THE RELATIONSHIP BETWEEN ALL EVENTS INITIALLY REPORTED AND ESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367685 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 B04950

    Patients

    Seq Age Sex Outcome Treatment
    1 Other