BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 2093978 · Received June 13, 2012

    Report

    Report Number
    2951250-2011-00023
    Event Type
    Other
    Date Received
    June 13, 2012
    Date of Event
    June 7, 2007
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IFU CONTRAINDICATION: THE ESSURE SYSTEM SHOULD NOT BE USED IN ANY PATIENT WITH KNOWN HYPERSENSITIVITY TO NICKEL CONFIRMED BY SKIN TEST (SEE WARNINGS SECTION BELOW FOR PATIENTS WITH SUSPECTED HYPERSENSITIVITY TO NICKEL). IFU WARNING: PATIENTS WITH SUSPECTED HYPERSENSITIVITY TO NICKEL SHOULD UNDERGO A SKIN TEST TO ASSESS HYPERSENSITIVITY PRIOR TO AN ESSURE PLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT CALLED TO REPORT A NICKEL ALLERGY AND THAT SHE DID NOT KNOW THERE WAS NICKEL IN THE INSERTS PRIOR TO HAVING THEM INSERTED. FOLLOW UP CALLS TO PATIENT TO OBTAIN ADDITIONAL INFORMATION WHICH WAS PROVIDED ON (B)(6) 2011. PATIENT WILL NOT DISCLOSE NAME OF HER PHYSICIAN. SHE HAS VISITED HER PHYSICIAN WHO RECOMMENDS REMOVAL, HOWEVER THE PATIENT STATES SHE CANNOT AFFORD REMOVAL AND HAS CHOSEN TO LIVE WITH THE PAIN. HER SYMPTOMS ARE PAIN DURING OVULATION AND BODY ACHES, SHE HAS BEEN TO THE EMERGENCY ROOM 4-5 TIMES FOR ABDOMINAL PAIN AND THEY TELL HER IT IS COMING FROM HER OVARIES. SHE HAS NOT HAD A CONFIRMATION TEST FROM AN ALLERGIST AS SHE SAYS SHE DOESN'T NEED TO BECAUSE SHE KNOWS SHE HAS A NICKEL ALLERGY AS SHE BREAKS OUT ANYTIME SHE WEARS CHEAP JEWELRY, WATCHES OR EARRINGS; SAYS IT IS HEREDITARY FROM MOTHER AND GRANDMOTHER, WHO HAVE EXPERIENCED THE SAME ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention