BEUDAMED
    FDA Adverse Event Other Summary report: N

    RHYTEC PORTRAIT PSR3

    MDR report key: 771467 · Received October 14, 2006

    Report

    Report Number
    3004948955-2006-00003
    Event Type
    Other
    Date Received
    October 14, 2006
    Date of Event
    October 15, 2005
    Report Date
    October 13, 2006
    Manufacturer
    RHYTEC, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS ATTRIBUTED TO DELAYED HEALING BECAUSE OF THE IDENTIFIED RISK FACTORS IN HER SELECTION AS A PT WITH THE CRITERIA OF THINNING EPIDERMIS AND RETIN-A USE, BOTH IDENTIFIED RISK FACTORS IN THE PRODUCT LABELING. IT IS RHYTEC'S OPINION THAT THE CONDITION OF THIS PT COULD RESOLVE WITHOUT THE SUGGESTED INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RHYTEC, INC. THAT A PT EXPERIENCED ATROPHIC SCARRING ON THE LEFT SIDE OF HER FACE. THE PHYSICIAN HAS SUGGESTED THAT SHE NOW UNDERGO ER-YAG LSR (SCITON) TREATMENT TO EVEN OUT THE ATROPHIC SCARRING. IT IS UNK AT THIS TIME IF THE PT HAS UNDERGONE THIS SUGGESTED MEDICAL INTERVENTION. THE PHYSICIAN ATTRIBUTES THE EVENT TO ADDITIONAL PULSES OF ENERGY DELIVERED IN A NON-UNIFORM MANNER AFTER THE FIRST PASS OF TREATMENT AS HE WAS UNCERTAIN AS TO THE COMPLETENESS OF COVERAGE. THE PT HAD SKIN THAT WAS THINNER THAN THE PHYSICIAN ANTICIPATED AND HAD BEEN USING ROTIN-A MORE RECENTLY THAN SHE SHOULD HAVE TO MEET PT CRITERIA FOR TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R