BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEN20 CONDUCTIVE PASTE

    MDR report key: 2526444 · Received April 4, 2012

    Report

    Report Number
    1718791-2012-00003
    Event Type
    Injury
    Date Received
    April 4, 2012
    Date of Event
    February 16, 2012
    Report Date
    April 2, 2012
    Manufacturer
    D.O. WEAVER AND CO.
    Product Code
    GYB
    PMA / PMN Number
    K883149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE BEEN AWAITING AN UPDATE FROM THE FOLLOW-UP THE PT WAS RECEIVING, BUT HAVE YET TO RECEIVE ANY UPDATES. IF WE RECEIVE ADDITIONAL PERTINENT INFO REGARDING THIS COMPLAINT, WE WILL SUBMIT A FOLLOW-UP REPORT TO THE FDA.

    Description of Event or Problem · 1

    PT UNDERWENT A SLEEP STUDY ON (B)(6) 2012. FOLLOWING THE TEST, HE WENT TO THE GYM FOR A WORK OUT. HIS PERSPIRATION REPORTEDLY MIXED WITH THE EEG PASTE AND DROPPED INTO HIS EYES, CAUSING REDNESS AND IRRITATION IN BOTH EYES. THE PT WENT TO AN OPHTHALMOLOGIST WHO DIAGNOSED HIM WITH CHEMICAL CONJUNCTIVITIS. PT COMPLAINED OF BLURRED VISION AND PAIN. HE WAS TREATED WITH EYE DROPS AND ANTIBIOTICS. ALTHOUGH SYMPTOMS IMPROVED AS OF (B)(6) 2012, PT CONTINUES TO COMPLAIN OF SYMPTOMS AND IS RECEIVING MEDICAL FOLLOW-UP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other