BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPREP

    MDR report key: 288834 · Received August 7, 2000

    Report

    Report Number
    1718791-2000-00004
    Event Type
    Injury
    Date Received
    August 7, 2000
    Date of Event
    July 1, 1997
    Report Date
    July 31, 2000
    Manufacturer
    D.O. WEAVER & CO.
    Product Code
    GYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT HAD A SLEEP STUDY IN 1997. PT GOT EITHER TEN20 OR OMNIPREP IN PT'S EYE AFTER TEST WAS COMPLETED. IT RAN INTO THE EYE WHEN PT TOOK A SHOWER. PT CLAIMS OF STILL HAVING TROUBLE SEEING THE COMPUTER AND IS SUING THE HOSP. ACCORDING TO THE ATTORNEY, THE PHYSICIAN WHO SAW PT INITIALLY SAID THAT THE EYE HAD SOME DAMAGE, BUT WOULD RECOVER. PT CLAIMS CONTINUED ISSUES WITH VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPREP SKIN PREP GEL GYB D.O. WEAVER & CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other TEN20 CONDUCTIVE PASTE.