BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE PERMANENT BIRTH CONTROL

    MDR report key: 4080888 · Received September 2, 2014

    Report

    Report Number
    MW5038137
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    June 27, 2014
    Report Date
    September 2, 2014
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, I HAD THE ESSURE PERMANENT BIRTH CONTROL INSERTED INTO MY FALLOPIAN TUBES. THE DOCTOR TOLD ME I WOULD BE "GOOD AS NEW THE NEXT DAY." I WAS NOT. I HAD SHARP PAINS IN MY ABDOMEN AND SHOOTING PAINS GOING DOWN MY LEGS. I BLED FOR OVER TWO WEEKS AND HAD SPOTTING FOR 2-3 WEEKS AFTER THAT. THE PAIN WOULD GET WORSE AFTER PROLONGED ACTIVITY AND MY HANDS AND FEET WOULD GET NUMB AND TINGLY. I GO MIGRAINES. AFTER MY INITIAL TWO WEEK CHECK UP, MY DOCTOR THOUGHT I MIGHT JUST HAVE AN INFECTION. SHE GAVE ME AN ANTIBIOTIC. THAT DID NOT MAKE ANYTHING BETTER SO SHE SCHEDULED A CT SCAN FOR (B)(6) 2014. ACCORDING TO THE DOCTOR THE CT SCAN SHOWED THAT THE PLACEMENT OF THE COILS WERE FINE AND THE DOCTOR DETERMINED THAT I WAS ALLERGIC TO THE COILS. I HAD THEM REMOVED (B)(6) 2014. I AM STILL RECOVERING FORM THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532129 ESSURE PERMANENT BIRTH CONTROL ESSURE HHS CONCEPTUS ESS305 B76537

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R