BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2993999

    MDR report key: 2993999 · Received March 1, 2013

    Report

    Report Number
    2993999
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    January 28, 2013
    Report Date
    March 1, 2013
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TIP WAS BENT WHEN PACKAGE OPENED, NOT ALLOWING IT TO BE CORRECTLY PASSED THROUGH THE OPERATIVE DEVICE. THE DEVICE WAS NOT USED ON THE PATIENT. NO PATIENT HARM.======================MANUFACTURER RESPONSE FOR PERMANENT BIRTH CONTROL- ESSURE, ESSURE (PER SITE REPORTER).======================WE PLAN TO RETURN THE DEVICE TO THE REP FOR EVALUATION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?DILATION AND HYSTEROSCOPY AND ESSURE TUBAL LIGATION.

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR UPON OPENING PACKAGE| DURING SURGERY, NOT USED ON PATIENT, DEVICE BENT