BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPULSE ENCORE

    MDR report key: 1644770 · Received February 12, 2010

    Report

    Report Number
    2914019-2010-00007
    Event Type
    Injury
    Date Received
    February 12, 2010
    Date of Event
    December 1, 2009
    Report Date
    February 12, 2010
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K022060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE EVENT DETAILS BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT CONCLUDED THE ROOT CAUSE OF THE REPORTED EVENT TO BE FAILURE OF THE PATIENT TO TAKE THE ANTIVIRAL MEDICATION PRESCRIBED BY THE USER FACILITY. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THE DEVICE OPERATED WITHIN SPECIFICATIONS AND FUNCTIONED TO FINISHED GOODS SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED A VIRAL OUTBREAK ON THE FACE AFTER TREATMENT WITH AN ULTRAPULSE ENCORE LASER. IT WAS FURTHER REPORTED THAT THE PATIENT DID NOT DISCLOSE THEIR PREDISPOSITION FOR VIRAL OUTBREAKS TO THE USER FACILITY PRIOR TO TREATMENT AND REFUSED TO TAKE THE PRESCRIBED ANTIVIRAL MEDICATION AFTER TREATMENT AND DISCLOSURE OF THE PREDISPOSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASER GEX RH USA, INC. 0642-415-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1