BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M22

    MDR report key: 3882077 · Received June 18, 2014

    Report

    Report Number
    3004135191-2014-00041
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 17, 2014
    Report Date
    June 18, 2014
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K083733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY'S PHYSICIAN ALLEGED THAT NO OPERATOR MANUAL WAS RECEIVED IN THE SHIPMENT OF THE SUBJECT DEVICE ON (B)(6) 2013. A REVIEW OF THE SUBJECT DEVICE SHIPMENT PACKAGING CHECKLIST CONFIRMED THE OPERATOR MANUAL WAS INCLUDED WITH THE SYSTEM WHEN SHIPPED TO THE USER FACILITY. THE LUMENIS M22 LASER IS A SELF-INSTALL SYSTEM. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THE DEVICE OPERATED TO MANUFACTURE SPECIFICATIONS. NO DEVICE MALFUNCTION WAS REPORTED OR OBSERVED. SUBJECT DEVICE MALFUNCTION IS NOT THE SUSPECTED CAUSE OF THE EVENT REPORTED. REASONABLE ATTEMPTS BY PHONE AND EMAIL WERE MADE TO OBTAIN FURTHER INFORMATION FROM THE USER FACILITY FOR THE REPORTED EVENT INCLUDING PATIENT INFORMATION, PATIENT PHOTOGRAPHS, TREATMENT SETTINGS, SUN EXPOSURE AND TEST PATCH, HOWEVER, NONE WAS RECEIVED; THEREFORE, LUMENIS IS UNABLE TO EVALUATE TREATMENT PARAMETERS TO DETERMINE THEIR APPROPRIATENESS FOR TREATMENT AND TO DETERMINE A CAUSE. SHOULD MORE INFORMATION WITH WHICH TO DETERMINE A CAUSE BE REPORTED, A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT TWO (2) PATIENTS SUSTAINED BLISTERS TO THE FACE FOLLOWING TREATMENT WITH A LUMENIS M22 LASER IPL HANDPIECE. IT WAS FURTHER REPORTED BY THE USER FACILITY'S PHYSICIAN THAT BOTH PATIENTS HAVE BEEN TREATED TO REMEDIATE THE ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359315 M22 INTENSE PULSE LIGHT DELIVERY DEVICE GEX LUMENIS, LTD. M22

    Patients

    Seq Age Sex Outcome Treatment
    1 Other