BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLELASE LASER SYSTEM

    MDR report key: 758404 · Received September 6, 2006

    Report

    Report Number
    1218402-2006-00145
    Event Type
    Injury
    Date Received
    September 6, 2006
    Date of Event
    October 22, 2003
    Report Date
    September 6, 2006
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CANDELA CORP IS NOT AWARE OF ANY FACTORS CONTRIBUTING TO INVOLVEMENT IN THIS CASE. FURTHER INFO TO BE DETERMINED IN LITIGATION.

    Description of Event or Problem · 1

    CANDELA CORP RECEIVED NOTICE THAT IT WAS A PARTY IN A LEGAL CIVIL ACTION. THE PLAINTIFF ALLEGES THAT CANDELA'S PRODUCT WAS DEFECTIVE IN DESIGN, CONSTRUCTION, AND MANUFACTURE LEADING TO THE PLAINTIFF'S INJURY. THE NOTICE ALLEGES THAT THE PLAINTIFF SUFFERED BURNS TO HER CHEST. THERE IS ALSO REFERENCE TO "PERMANENT PERSONAL INJURIES." THE CANDELA PRODUCT INVOLVED WAS NOT IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLELASE LASER SYSTEM DERMATOLOGY LASER GEX CANDELA CORP. 9914-00-0880 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other