BEUDAMED
    FDA Adverse Event Other Summary report: N

    RHYTEC PORTRAIT PSR3

    MDR report key: 770373 · Received October 14, 2006

    Report

    Report Number
    3004948955-2006-00004
    Event Type
    Other
    Date Received
    October 14, 2006
    Report Date
    October 13, 2006
    Manufacturer
    RHYTEC INCORPORATED
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED AREA IS OVER AN AREA OF SKIN THAT WOULD HAVE BEEN UNDERMINED AS PART OF A FACE LIFT AND THEN STRETCHED. WHEN A THINNING EPIDERMIS IS INVOLVED, THE ENERGY USED SHOULD BE REDUCED. THE ROOT CAUSE OF THIS EVENT WOULD BE A THINNED EPIDERMIS SECONDARY TO A FACE LIFT AND USER ERROR IN ENERGY SELECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RHYTEC, INC. THAT A PATIENT EXPERIENCED DELAYED HEALING OF THE CHEEKS WITH A SUBSEQUENT ATROPHIC SCARRING AND UNDULATED SURFACE MOSTLY OVER HER LEFT CHEEK. THE PATIENT HAD A FACELIFT TWO YEARS EARLIER. THIS WAS FULL FACE TREATMENT. THE PATIENT IS NOW UNDERGOING A SERIES OF 1319NM (SCITION THERMASCAN) ND-YAG LASER TREATMENTS OVER THE AFFECTED AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHYTEC PORTRAIT PSR3 ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI RHYTEC INCORPORATED 745000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R