BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURYSM CLIP C-2200

    MDR report key: 472042 · Received July 14, 2003

    Report

    Report Number
    1222632-2003-00013
    Event Type
    Injury
    Date Received
    July 14, 2003
    Report Date
    July 9, 2003
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    HCH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    "PT RECEIVED CLIP IMPLANTATION IN 2002 AND APPROX TWO WEEKS POST IMPLANT, DEVELOPED A RASH ON THEIR NECK WHICH HAS TRAVELED DOWN THEIR WHOLE BODY. THE PT HAS BEEN EVALUATED BY THEIR NEUROSURGEON AND BY SEVERAL DERMATOLOGISTS WHO HAVE RULED OUT NEARLY ALL ALLERGIES AND ARE CONSIDERING THEIR ANTI HYPERTENSIVE MEDICATION AND THE IMPLANT OF THE TITANIUM CLIPS AS A POSSIBLE CAUSE OF THEIR DERMATITIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURYSM CLIP C-2200 ANEURYSM CLIP HCH NMT MEDICAL, INC. C-2200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN