BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MW5030651

    MDR report key: 3193361 · Received June 21, 2013

    Report

    Report Number
    MW5030651
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    February 21, 2013
    Report Date
    June 21, 2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ESSURE WAS IMPLANTED (B)(6) 2013. THE PROCEDURE WENT WELL. THE FOLLOWING TWO DAYS WERE ALSO INCIDENT FREE. THE THIRD DAY HOWEVER, THE PT DESCRIBED FEELING A CRAMPING SENSATION DIRECTLY WHERE THE ESSURE DEVICES WERE IMPLANTED. THIS CRAMPING NEVER SUBSIDED NOR WAS IT EASILY TREATED WITH OVER THE COUNTER PAIN MEDICATION. THE PT RETURNED TO HER IMPLANTING DOCTOR TWICE BEFORE THE 3 MONTH HSG TEST AND REPORTED MORE PAIN IN THE LOWER BACK. REMOVAL IS REQUIRED FOR RELIEF OF SYMPTOMS. REASON FOR USE: PERMANENT STERILIZATION.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention| S