BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEN20 CONDUCTIVE PASTE

    MDR report key: 2483443 · Received March 5, 2012

    Report

    Report Number
    1718791-2012-00001
    Event Type
    Injury
    Date Received
    March 5, 2012
    Date of Event
    February 6, 2012
    Report Date
    February 23, 2012
    Manufacturer
    D.O. WEAVER AND COMPANY
    Product Code
    GYB
    PMA / PMN Number
    K883149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAW OPHTHALMOLOGIST, WHO STATED THAT THERE WAS NO TEN20 PASTE IN THE EYE. HE ALSO STATED THAT THERE WAS NO DAMAGE TO THE CORNEA, AND THAT THE PAIN WAS COMING FROM IRRITATION TO THE MUCUS MEMBRANE OF THE EYE. PATIENT WAS TREATED WITH STEROID EYE DROPS AND PAIN MEDICATION. NO PERMANENT DAMAGE TO THE EYE IS ANTICIPATED.

    Description of Event or Problem · 1

    PATIENT HAD EEG PERFORMED AT HEART HOSPITAL OF FLORIDA ON (B)(6), 2012. PATIENT'S FAMILY LATER CONTACTED THE EEG DEPARTMENT STATING THAT THE PATIENT HAD EYE IRRITATION/SWELLING. FAMILY MEMBER STATED THAT THE PATIENT INADVERTENTLY GOT TEN20 PASTE (THAT WAS LEFT IN THE HAIR AFTER THE PROCEDURE) INTO HER EYE. FAMILY TRIED TO FLUSH OUT THE EYE, BUT THE EYE WAS STILL IRRITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEN20 CONDUCTIVE PASTE TEN20 PASTE GYB D.O. WEAVER AND COMPANY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other