BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRAPULSE 5000C 117V

    MDR report key: 77106 · Received March 13, 1997

    Report

    Report Number
    2914019-1997-00007
    Event Type
    Other
    Date Received
    March 13, 1997
    Date of Event
    June 6, 1996
    Report Date
    March 13, 1997
    Manufacturer
    COHERENT MEDICAL GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION IS THAT INJURY WAS DUE TO THE PT'S PARTICULAR SKIN PHYSIOLOGY. COHERENT HAS ADDED TO THE ULTRAPULSE OPERATOR MANUAL, "POSTOPERATIVE INFECTION" AS A POTENTIAL COMPLICATION AND HAS ADDED "CAUTION: DELAYED WOUND HEALING AND/OR THE ONSET OF FACIAL PAIN MAY BE AN INDICATION OF INFECTION AND SHOULD BE QUICKLY EVALUATED.."

    Description of Event or Problem · 1

    NON HEALING EXUDATIVE DERMATITIS OF FACE. NO DEFINITE ETIOLOGY DETERMINED. (DELAYED HEALING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPULSE 5000C 117V SURGICAL LASERS GEX COHERENT MEDICAL GROUP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other