BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 1192408 · Received September 30, 2008

    Report

    Report Number
    2951250-2008-00025
    Event Type
    Other
    Date Received
    September 30, 2008
    Date of Event
    July 28, 2008
    Report Date
    February 14, 2017
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    MEDWATCH REPORTED THAT A MICRO-INSERT IMPLANTED IN 2008 WAS REMOVED 5 DAYS POST-IMPLANT. INCIDENT DESCRIPTION SUGGESTS THAT DEVICE WAS IMPLANTED IN A PT WITH ALLERGY TO NICKEL. EVENT REPORTED ANONYMOUSLY; NO FURTHER INFO COULD BE OBTAINED. ACCORDING TO THE ESSURE INSTRUCTIONS FOR USE, IT IS CONTRAINDICATED FOR THE ESSURE SYS TO BE USED IN A PT WITH "KNOWN HYPERSENSITIVITY TO NICKEL CONFIRMED BY SKIN TEST." PTS WITH SUSPECTED HYPERSENSITIVITY TO NICKEL SHOULD UNDERGO A SKIN TEST TO ASSESS HYPERSENSITIVITY PRIOR TO ESSURE PLACEMENT PROCEDURE. ADDITIONALLY, PHYSICIAN TRAINING EMPHASIZES THAT NICKEL ALLERGY IS A CONTRAINDICATION FOR MICRO-INSERT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE INSERT, TUBAL OCCLUSION HHS CONCEPTUS, INC. ESS305 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention