BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYNA-FLEX

    MDR report key: 73142 · Received March 3, 1997

    Report

    Report Number
    MW1010876
    Event Type
    Other
    Date Received
    March 3, 1997
    Date of Event
    October 14, 1996
    Manufacturer
    ORTHO ORGANIZERS
    Product Code
    EIG
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RINSED EXCESS GEL ETCH FROM LOWER SECOND MOLAR. EITHER WETTING CHEEK RETRACTORS OR SPATTER CAUSED GEL ETCH CONTACT W/LOWER LIP. CAUSING HYPEREMIC DECORNIFIED "BLEMISH". PT REFERRED TO PLASTIC SURGEON. 2/11/97 FOLLOW-UP GREY APPEARED NEARLY NORMAL, USED TROPICAL COLTIZONE OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNA-FLEX CHEEK RETRACTOR EIG ORTHO ORGANIZERS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other EVALUATION TREATMENT PROVIDED