BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MW5059458

    MDR report key: 5381863 · Received January 20, 2016

    Report

    Report Number
    MW5059458
    Event Type
    Injury
    Date Received
    January 20, 2016
    Date of Event
    February 26, 2011
    Report Date
    March 14, 2016
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). IMPLANTED WITH ESSURE (B)(6) 2011, SHORTLY AFTER STARTED HAVING COUGHING, WHEEZING WENT TO DR WAS TOLD IT WAS BRONCHITIS, THIS LASTED ABOUT 16 WEEKS WITH NO MEDICATIONS HELPING AND WAS SENT TO AND ALLERGIST/ ASTHMA SPECIALIST WHOM DIAGNOSED AS A FOOD PRESERVATIVE ALLERGY. IN 2012 STARTED HAVING HEADACHES, ACHES AND PAINS OVER MY WHOLE BODY, SEVERE BACK PAIN. DID PHYSICAL THERAPY. WEIRD SOUNDS IN MY HEAD AND LEFT EAR. TO THIS DAY I CAN STILL HEAR A WHOOSHING SOUND IN IT. IN 2014 WENT IN FOR ROUTINE EYE EXAM AND WAS SENT TO MY PCP FOR REFERRAL FOR MRI AND LAB WORK. LAB WORK SHOWED HIGH INFLAMMATION IN THE BODY. EYE DR SUSPECTED I HAD A BRAIN TUMOR. MRI WAS CLEAR NO ABNORMALITIES. SENT TO NEUROLOGIST DUE TO MY MS LIKE SYMPTOMS ALONG WITH OPTIC NERVE ISSUES. HAND, FEET TINGLING, SEVERE MUSCLE SPASMS ALONG WITH FAMILY HISTORY. NEUROLOGISTS FOUND NO SIGNS OF MS. ACHES AND PAINS ALONG WITH THE MUSCLE SPASMS AND JOINT PAIN ARE STILL PRESENT DAILY. I ALSO HAVE SEVERE PAINS IN PELVIC REGION WHEN I AM OVULATING ALONG WITH BACK PAIN.

    Description of Event or Problem · 1

    (B)(4). PELVIC PAIN HAS INCREASED ALONG WITH SEVERE LOWER BACK PAIN WORSE THAN HAVING BACK LABOR WHEN I HAD MY KIDS. WILL BE HAVING ESSURE REMOVED DURING A LAVH WITH BS ON (B)(6) 2016.

    Patients

    Seq Age Sex Outcome Treatment
    1 35.000 YR Other