BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP EXTRA TITANIUM CLIPS

    MDR report key: 3092248 · Received May 3, 2013

    Report

    Report Number
    3005075853-2013-02122
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K830503
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED FROM THE DERMATOLOGIST: "PATIENT COMPLAINED OF CHRONIC PAIN AT SITE OF CLIP IN BREAST FOLLOWING A SURGICAL BIOPSY. THERE ARE VERY RARE REPORTS OF METAL ALLERGY CAUSING SYSTEMIC SYMPTOMS (PAIN, FEVER, HYPERTENSION, TACHYCARDIA). TESTING TO ALL AVAILABLE METALS IN OUR STOCK, INCLUDING TITANIUM, WERE NEGATIVE FOR A TYPE IV HYPERSENSITIVITY REACTION (ALLERGIC CONTACT DERMATITIS) AND TESTING TO NICKEL, CHROMATE, COBALT AND TITANIUM WERE NEGATIVE FOR A TYPE I HYPERSENSITIVITY REACTION (URTICARIA). THE PATIENT DID NOT RECEIVE ANY MEDICAL TREATMENT. PATIENT AND SURGEON ARE CONSIDERING REMOVING THE CLIP."

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MY PATIENT IS CONCERNED. SHE MAY BE HAVING AN ALLERGIC REACTION TO THE METAL USED IN A SURGICAL CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195362 LIGACLIP EXTRA TITANIUM CLIPS CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4C20E

    Patients

    Seq Age Sex Outcome Treatment
    1