BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS V

    MDR report key: 6175024 · Received December 15, 2016

    Report

    Report Number
    2954354-2016-00003
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 16, 2016
    Report Date
    November 30, 2016
    Manufacturer
    CUTERA, INC
    Product Code
    GEX
    PMA / PMN Number
    K153671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    CUTERA REVIEWED CLINICAL GUIDANCE FOR TREATMENT OF SCARS TO THE DEVICE OPERATOR. NOT A DEVICE PERFORMANCE COMPLAINT.

    Additional Manufacturer Narrative · 1

    CUTERA SENT CLINICAL GUIDANCE FOR TREATMENT OF SCARS TO THE DEVICE OPERATOR FOR REVIEW. CUTERA HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE DEVICE OPERATOR TO OBTAIN SPECIFIC TREATMENT INFORMATION. CUTERA WILL CONTINUE TO MAKE ATTEMPTS TO CONTACT THE DEVICE OPERATOR TO DISCUSS THE TREATMENT TECHNIQUE AND SCAR ASSESSMENT FOR DECREASED SENSATION / NUMBNESS. THE DECREASED SENSATION / NUMBNESS OF ABDOMINOPLASTY SCAR IS A COMMON SIDE EFFECT. SCARS WITH DECREASED SENSIBILITY TO HOT TEMPERATURES ARE AT A HIGHER RISK OF BURN INJURY. NOT A DEVICE PERFORMANCE COMPLAINT.

    Description of Event or Problem · 1

    THE FULL THICKNESS BURN INJURY (<1% TBSA WITH ESCHAR FORMATION) ON A ABDOMINOPLASTY INCISION SCAR THAT REQUIRED PROFESSIONAL WOUND MANAGEMENT DURING THE SKIN HEALING PROCESS. THE DEPTH OF BURN IS HIGH RISK FOR HEALING WITH SCAR FORMATION. THERE IS NOT A DEVICE PERFORMANCE COMPLAINT ASSOCIATED WITH THE CLINICAL EVENT. BURNS ARE A KNOWN AND WELL DOCUMENTED RISK OF THE PROCEDURE. SPECIFIC INFORMATION ABOUT THE TREATMENT TECHNIQUE AND SCAR SENSIBILITY TO HOT / COLD TEMPERATURES.

    Description of Event or Problem · 1

    THE FULL THICKNESS BURN INJURY (<1% TBSA WITH ESCHAR FORMATION) ON A ABDOMINOPLASTY INCISION SCAR THAT REQUIRED PROFESSIONAL WOUND MANAGEMENT DURING THE SKIN HEALING PROCESS. THE DEPTH OF BURN IS HIGH RISK FOR HEALING WITH SCAR FORMATION. THERE IS NOT A DEVICE PERFORMANCE COMPLAINT ASSOCIATED WITH THE CLINICAL EVENT. BURNS ARE A KNOWN AND WELL DOCUMENTED RISK OF THE PROCEDURE. SPECIFIC INFORMATION ABOUT THE TREATMENT TECHNIQUE AND SCAR SENSIBILITY TO HOT / COLD TEMPERATURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827113 GENESIS V POWERED LASER SURGICAL INSTRUMENT GEX CUTERA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R