BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3900343 · Received June 27, 2014

    Report

    Report Number
    MW5036858
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 23, 2014
    Report Date
    May 4, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS GOING TO GO GET A BALL THAT ROLLED PAST THE KIDS AND I WAS WALKING, GRASS WAS DRY, ALL OF A SUDDEN - MY BODY LITERALLY FROZE - I HAD NO CONTROL OVER ARMS, LEGS, NECK, HEAD AND I FELL VERY AWKWARDLY TO THE GROUND. TODAY I HURT ALL OVER. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376751 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 45.000 YR Other| S HYZAAR, CYMBALTA, ATIAVAN, SEROQUEL, PREMARIN