BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4454908 · Received January 27, 2015

    Report

    Report Number
    MW5040407
    Event Type
    Injury
    Date Received
    January 27, 2015
    Date of Event
    December 29, 2014
    Report Date
    December 29, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). HAD INTENSE DEBILITATING CRAMPING THE DAY OF IMPLANTATION OF WHICH I GOT USED TO USING OTC PAIN MEDS. I COULD STILL FUNCTION UNLESS IT WAS COMING UP ON A PERIOD. THE CRAMPING AND SEVERE BLOOD FLOW (1 SUPER PLUS TAMPON PER HR W/ A MAXI PAD) AND BECAME QUICKLY ANEMIC. THE LOWER BACK PAIN WAS INTENSE AND MADE MY ROUTINE EXERCISE OF RUNNING UNBEARABLE. WHICH, SET UP THE DEPRESSION AND ANXIETY THAT WOULD LAST FOR THE YEARS TO COME. I HAD NO IDEA PAIN WOULD HAVE SUCH AN IMPACT EMOTIONALLY. SOME MONTHS, I WOULD HAVE MIGRAINES-I DID NOT HAVE THAT PROBLEM IN MY LIFE. I'VE HAD MONTHS WHERE THE BLOATING AND PAIN WAS SO BAD I WOULD VOMIT REPEATEDLY. WE DID NOT HAVE INSURANCE DURING THOSE YEARS, BUT WERE SELF-EMPLOYED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61344 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 43.000 YR Hospitalization| L| O