BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPREP PASTE

    MDR report key: 199357 · Received November 24, 1998

    Report

    Report Number
    1718791-1998-00003
    Event Type
    Injury
    Date Received
    November 24, 1998
    Date of Event
    December 29, 1997
    Report Date
    November 16, 1998
    Manufacturer
    WEAVER AND CO.
    Product Code
    GYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INSURANCE AGENT DESCRIBED A CLAIM FOR INJURY INVOLVING A LOSS OF PIGMENTATION WHICH OCCURRED DURING A SLEEP STUDY. PT HAS DISCOLORATION OR DESCRIBED LOSS OF PIGMENT ON HER CALVES AND ON HER NECK. PT IS A FEMALE AFRICAN AMERICAN. THERE ARE REPORTED TO BE TWO SPOTS ON HER NECK AND FOUR SPOTS ON HER CALVES. SOURCE REPORTED LATER THAT OMNIPREP, MAY NOT HAVE BEEN INVOLVED. LATER AGAIN, SOURCE REPORTED THAT OMNIPREP WAS INVOLVED. SOURCE ALSO WANTED TO SEE THAT PT TO CONFIRM THE CLAIM THAT SHE WAS MAKING. CO DISCUSSED THIS INCIDENT WITH SOURCE TODAY AND HE IS NOT ABLE YET TO SEE THE PT. CO DECIDED THAT ALTHOUGH THE SEVERITY OF THE INCIDENT REMAINS IN QUESTION, THAT CO WOULD SUBMIT IT AS AN MDR REPORTABLE INCIDENT RATHER THAN PROLONGING FURTHER THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPREP PASTE ABRASIVE PASTE GYB WEAVER AND CO. 10-10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other