BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLE LASE PRO

    MDR report key: 2440345 · Received February 1, 2012

    Report

    Report Number
    1218402-2012-00002
    Event Type
    Injury
    Date Received
    February 1, 2012
    Date of Event
    December 30, 2011
    Report Date
    February 1, 2012
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS INSTALLED AT THE USER SITE (B)(6) 2011. THERE HAVE BEEN NO CLINICAL COMPLAINTS FROM THE USER SITE OR REGARDING THIS SPECIFIC SERIAL NUMBER SINCE THAT TIME. THE PRODUCT DEVICE HISTORY RECORD AND SERVICE HISTORY WERE REVIEWED (B)(4) 2012 WITH NO CONCLUSIONS MADE. THE TREATMENT PARAMETERS REPORTEDLY USED BY THE OPERATOR WERE: 15MM SPOT SIZE, 30MS PULSE DURATION, 30J/CM2, WHICH ARE NOT WITHIN THE PARAMETERS FOR THE PT'S SKIN TYPE AS RECOMMENDED BY (B)(4) TREATMENT GUIDELINES. BASED ON WHAT WAS REPORTED BY THE SITE, THE TREATMENT PARAMETERS THAT WERE USED MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT RECEIVED A LASER HAIR REMOVAL TREATMENT ON BOTH LEGS. THE PT RETURNED TO THE SITE THE NEXT MORNING TO REPORT THAT SHE HAD RECEIVED BURNS ONLY ON HER LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLE LASE PRO DERMATOLOGY LASER GEX CANDELA CORP. 9914-00-9015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability