BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELASHAPE

    MDR report key: 2750329 · Received September 14, 2012

    Report

    Report Number
    3004772125-2012-00004
    Event Type
    Injury
    Date Received
    September 14, 2012
    Date of Event
    April 6, 2012
    Report Date
    September 1, 2012
    Manufacturer
    SYNERON MEDICAL LTD.
    Product Code
    NUV
    PMA / PMN Number
    K071872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS SYNERON PROCEDURE TO REQUEST A SYSTEM THAT WAS USED IN A PROCEDURE THAT ENDED WITH AN INJURY TO BE EXAMINED. THE CLINIC (SYNERON CUSTOMER) REFUSED AND STATED THAT THE SYSTEM IS WORKING PROPERLY TO THEIR SATISFACTION. THE CLINIC DID NOT ANSWER SYNERON REQUEST FOR MORE INFO ON THE EVENT, SYSTEM SETTING, PT PREVIOUS TREATMENTS, OPERATOR TRAINING RECORDS, ETC. DUE TO LACK OF COOPERATION FROM THE CLINIC AND BASED ON PT COMPLAINT, ONLY THE MOST PROBABLE ROOT CAUSE OF THIS INJURY IS A USER ERROR NOT FOLLOWING SYNERON CLINICAL GUIDE.

    Description of Event or Problem · 1

    SYNERON WAS MADE AWARE ON (B)(6) 2012, OF AN INJURY SUSTAINED BY A FEMALE PT WHO RECEIVED TREATMENT WITH A SYNERON PRODUCT ON (B)(6) 2012. THE COMPLAINT ARRIVED IN A FORM OF A LETTER FROM THE PT'S LAWYER ADDRESSED TO THE MEDICAL DIRECTOR OF THE CLINIC WHERE THE PT WAS TREATED. THE TREATMENT AND INJURY WAS DESCRIBED IN THIS LETTER. PT WAS TREATED WITH THE VELASHAPE SYSTEM ON THE ARM AREA BY TECH. THE TECH STARTED THE TREATMENT ON THE LOWEST SETTING, AND MANEUVERED THE DEVICE'S VACUUM IN A VERTICAL MOTION, MASSAGING THE PT'S RIGHT ARM. INITIALLY, THE TECH WOULD CHECK THE SKIN AFTER EACH STROKE. THE TECH INCREASED THE INTENSITY OF THE TREATMENT, AND BEGAN USING HER PHONE, AND LEFT THE MACHINE STATIONARY ON THE ONE PART OF THE PT'S RIGHT ARM. THE PT COMPLAINED ABOUT DISCOMFORT. AFTER DECREASING THE DEVICE SETTING, THE TECH NOTIFIED THE PT THAT A BLISTER WAS FORMING ON HER ARM FROM THE TREATMENT. THE PT SOUGHT CARE FROM HER PRIMARY PHYSICIAN AND URGENT CARE, AND WAS PRESCRIBED SILVADENE, STEROID INJECTION, AND ANTIBIOTIC. DURING FOLLOW UP WITH THE EMERGENCY PHYSICIAN ON (B)(6) 2012, THE DOCTOR NOTICED THAT THE BURN WAS NOT HEALING AND CONSULTED WITH A PLASTIC SURGEON WHO DIAGNOSED THE PT WITH A 3RD DEGREE BURN AND RECOMMENDED SKIN GRAFT TO HELP HEAL THE WOUND AND LESSEN THE APPEARANCE OF A SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VELASHAPE MASSAGER, VACUUM NUV SYNERON MEDICAL LTD. FG00121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S