BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 4924177 · Received July 16, 2015

    Report

    Report Number
    2411236-2015-00005
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 17, 2015
    Report Date
    June 17, 2015
    Manufacturer
    A.R. MEDICOM INC. (SHANGHAI) LTD.
    Product Code
    EFN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    TWO FEMALE PATIENTS HAD EXPERIENCED BLISTERING AND REDNESS IMMEDIATELY AFTER A ROUTINE PROCEDURE. AS A RESULT BOTH FEMALE PTS WERE PRESCRIBED KENALOG CREAM TO HELP TREAT THE BLISTERING AND REDNESS.

    Description of Event or Problem · 2

    TWO FEMALE PATIENT HAD EXPERIENCED BLISTERING AND REDNESS IMMEDIATELY AFTER A ROUTINE PROCEDURE. AS A RESULT BOTH FEMALE PTS WERE PRESCRIBED KENALOG CREAM TO HELP TREAT THE BLISTERING AND REDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463466 HENRY SCHEIN COTTON ROLLS #2 NON STERILE EFN A.R. MEDICOM INC. (SHANGHAI) LTD. 18636

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other
    2 Other