BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3463362 · Received November 6, 2013

    Report

    Report Number
    2951250-2013-00032
    Event Type
    Injury
    Date Received
    November 6, 2013
    Date of Event
    September 18, 2013
    Report Date
    April 19, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE CODE KNH WAS REPLACED WITH HHS.

    Additional Manufacturer Narrative · 1

    PTC FINAL RESULT RECEIVED ON 30-JAN-2014. PTC GLOBAL NUMBER: (B)(4). FINAL ASSESSMENT: LOT HISTORY RECORD (LHR) REVIEWED. PRODUCT MET PRODUCT RELEASE SPECIFICATIONS. NO DEVICE RETURNED; THEREFORE, NO DEVICE INVESTIGATION COULD BE COMPLETED. NO CONCLUSIONS CAN BE DRAWN. NO CAPA INVESTIGATION IS REQUIRED PER CRITERIA ESTABLISHED IN (B)(4), "PROCESSING ESSURE CASES IN DEV@COM." MEDICAL ASSESSMENT: THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE FOR A QUALITY DEFICIT PER SE. APPROX (B)(4) FURTHER AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH NO. 893037, BUT NONE OF THOSE CASES REFER TO A SIMILAR ADVERSE TYPES OF EVENTS. NO BATCH SIGNAL COULD BE IDENTIFIED. THE REVIEW OF THE LOT HISTORY RECORDS FOUND THAT THE PRODUCT MET PRODUCT RELEASE SPECIFICATIONS. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. AT THE TIME OF THIS MEDICAL EVALUATION THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". IN SUMMARY, BASED ON THE AVAILABLE INFORMATION THERE IS NO REASON TO SUSPECT QUALITY DEFECT. DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    A CUSTOMER HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN JUNE 2012. IN JULY 2012 HER RIGHT LEG WENT COMPLETELY NUMB. TWO DAYS LATER FEELING IN LEG CAME BACK, EXCEPT FOR IN RIGHT FOOT FROM MIDDLE TOE TO PINKY TOE AND HER HEEL, WHICH STAYED NUMB FOR 2 MORE WEEKS. SHE ALSO EXPERIENCED MAJOR CRAMPS IN LOWER PELVIC AREA, NON-STOP HURTING, AND EXCESSIVE BLEEDING WITH EVERY PERIOD. AFTER A FEW MONTHS SHE NOTICED THAT HER HAIR WAS FALLING OUT COMPLETELY. SHE WENT TO 3 DIFFERENT EMERGENCY ROOMS, HER LAST ONE DUE TO SEVERE PAIN. ON (B)(6) 2013, A PARTIAL HYSTERECTOMY (REMOVED UTERUS AND TUBES) WAS PERFORMED. SHE ALSO REMOVED THE ESSURE INSERTS. IT WAS REPORTED THAT A HYSTEROSALPINGOGRAM CONFIRMATION TEST WAS NEVER DONE. SHE REPORTED SHE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571620 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893037 10888853003051
    572207 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893037 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention| O DILAUDID| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]