BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUPREP GEL DEVICE #1

    MDR report key: 1624789 · Received March 3, 2010

    Report

    Report Number
    1718791-2010-00003
    Event Type
    Other
    Date Received
    March 3, 2010
    Date of Event
    February 10, 2010
    Report Date
    March 3, 2010
    Manufacturer
    D.O. WEAVER AND COMPANY
    Product Code
    GYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LAB HAS NOT HEARD BACK FROM PATIENT, THEREFORE, WE COULD NOT DETERMINE SEVERITY OF INJURY AT THIS TIME. ASSUMED TO BE MINOR SINCE PATIENT HAS NOT MADE CONTACT WITH THE SLEEP LAB, BUT CANNOT CONFIRM.

    Description of Event or Problem · 1

    CLINICAL MANAGER OF SOUTHEAST REGIONAL SLEEP DISORDER CENTER IN (B)(6) CALLED TO SAY THAT A PATIENT HAD A SLEEP STUDY. CALLED THE NEXT DAY TO SAY THAT HER EYES WERE IRRITATED AND SHE HAD BLURRED VISION. TOLD BY LAB TO RINSE EYES WITH ISOTONIC SALINE SOLUTION. WE SUGGESTED AN EXTENDED SHOWER RINSING EYES WITH WATER AS WARM AS COMFORTABLE. LAB HAS NOT FOLLOWED UP WITH PATIENT AS OF THIS DATE. PATIENT IS SCHEDULED IN FOR ANOTHER EXAM NEXT WEEK, BUT STATUS OF INJURY NOT CONFIRMED AS OF THIS DATE. LIKELY NOT PERSISTING BECAUSE, PATIENT HAS MADE NO FURTHER CONTACT WITH LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUPREP GEL DEVICE #1 SKIN PREP GEL GYB D.O. WEAVER AND COMPANY 10-30 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TEN20 CONDUCTIVE PASTE (B)(6)2010