BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3092163 · Received May 1, 2013

    Report

    Report Number
    MW5030021
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    April 26, 2012
    Report Date
    May 1, 2013
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT REC'D THE DEVICE IN (B)(6) 2012 WHEN SHE IMMEDIATELY BEGAN EXPERIENCING THE FOLLOWING ADVERSE REACTIONS: CRAMPS, HEADACHE, DIARRHEA, DIZZINESS, NUMBNESS, BLURRED VISION, FATIGUE, FEVER, CHILLS, BODY ACHES, FOOD SENSITIVITY, LOSS OF APPETITE, TENDER ABDOMEN, SHARP PAIN, BACK ACHE, CHEST PAIN FEELING LIKE HEART ATTACK, NICKLE TASTE IN THE MOUTH, HAIR LOSS, WEIGHT GAIN, PUNCTURED TUBES, PAINFUL SEX, CAN'T DRINK FLUIDS AT NIGHT. PT ENDED UP HAVING TOTAL HYSTERECTOMY AND SHE IS STILL SUFFERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189632 ESSURE ESSURE HHS CONCEPTUS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Life Threatening| R