BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3901763 · Received June 23, 2014

    Report

    Report Number
    MW5036871
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    July 31, 2008
    Report Date
    June 25, 2014
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT REPORTS FEELING SICK IMMEDIATELY AFTER IMPLANT OF ESSURE. PT EXPERIENCED PROFUSE BLEEDING, HAIR LOSS, MEMORY LOSS, NAUSEA, VOMITING, MUSCLE PAIN, SEVER ABDOMINAL PAIN, BLOATING, CONFUSION, HIGH BLOOD PRESSURE, VISION PROBLEMS, TEETH AND GUM PROBLEMS, AND LETHARGY. "I FEEL LIKE AN 80 YEAR OLD LADY". PT ALSO REPORTS HAVING STABBING PAIN AND BURNING SENSATION BUT SUBSIDED A LITTLE AFTER 1CM OF ESSURE WAS EXPLANTED BY PHYSICIAN ON (B)(6) 2013. DURING THE EXPLANT PHYSICIAN WAS ONLY ABLE TO GET 1CM OUT OF THE 4CM IMPLANTED THIS WAS DUE TO DEVICE FRAGMENTATION. A 3CM OF DEVICE HAS MIGRATED TO PT'S RIBS AND HIPS. EXPLANTING PHYSICIAN ALSO REALIZED THE IMPLANTING PHYSICIAN PERFORMED A TUBAL AS WELL AND HER FALLOPIAN TUBES WERE PERFORATED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366103 ESSURE ESSURE HHS CONCEPTUS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR