BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUPREP GEL

    MDR report key: 480854 · Received August 26, 2003

    Report

    Report Number
    1718791-2003-00003
    Event Type
    Other
    Date Received
    August 26, 2003
    Date of Event
    July 23, 2003
    Report Date
    August 26, 2003
    Manufacturer
    D.O. WEAVER & CO.
    Product Code
    GYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD A SLEEP STUDY. TECH IS WELL TRAINED AND DOES NOT OVER ABRADE ACCORDING TO LAB DIRECTOR. SLEEP STUDIES ARE VIDEO TAPED AND LAB DIRECTOR WILL REVIEW. PT CALLED LAB ON AUG 7TH 2003. HAD BEEN TO A BEAUTICIAN AND BEAUTICIAN HAD NOTICED HAIR LOSS ON 5 SPOTS INCLUDING ONE ABOUT THE SIZE OF A QUARTER AT CZ (CROWN OF HEAD). PT SAID THE PROCEDURE WAS NOT PAINFUL. NO SCABBING BUT AREA SLIGHTLY RED ACCORDING TO THE PT. BEAUTICIAN IS CONCERNED THAT HAIR MAY NOT GROW BACK IN THESE SPOTS. THEY USED ELEFIX PASTE AND 12-14 SITES ON THE SCALP. THEY USED NUPREP TO PREP THE SKIN. THEY READ MSDS TO PT AND INSTRUCTIONS. PT WANTED TO KNOW IF MD SHOULD BE INVOLVED AND THE LAB DIRECTOR TOLD PT YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUPREP GEL SKIN PREP GEL GYB D.O. WEAVER & CO. 10-30 465

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other ELEFIX PASTE (2003).