BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENIS ONE

    MDR report key: 1760673 · Received July 14, 2010

    Report

    Report Number
    2914019-2010-00035
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 8, 2010
    Report Date
    July 14, 2010
    Manufacturer
    LUMENIS LTD. YOKNEAM
    Product Code
    GEX
    PMA / PMN Number
    K060448
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE REPORTED EVENT DETAILS BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT CONCLUDED THE PROBABLE ROOT CAUSE OF THE INCIDENT OCCURRING TO THE IPL PT TO BE INAPPROPRIATE SKIN TYPING BY THE DEVICE OPERATOR. ADDITIONALLY, A LUMENIS MEDICAL MATTER EXPERT CONCLUDED THAT A TEST PATCH WAS NOT COMPLETED ON THE AREA BEING TREATED IN CONTRAINDICATION TO DFU. REASONABLE ATTEMPTS WERE MADE TO CONTACT THE USER FACILITY FOR ADD'L INFO REGARDING THE HAIR REMOVAL PT, HOWEVER, NONE WAS PROVIDED. SHOULD ADD'L INFO BE REPORTED, A F/U MDR WILL BE FILED. AN EVAL OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL SPECIALIST CONFIRMED THAT THERE WAS NO RELATED DEVICE MALFUNCTION AND THE DEVICE PERFORMED WITHIN ACCEPTABLE PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE PT SUSTAINED HYPOPIGMENTATION TO THE FACE AFTER IPL TREATMENT WITH A LUMENIS ONE LASER AND ONE PT SUSTAINED BLISTERS TO THE BACK AFTER LASER HAIR REMOVAL TREATMENT WITH A LUMENIS ONE LASER, LIGHTSHEER HEAD. IT WAS FURTHER REPORTED THAT BOTH PATIENTS WERE GIVEN LICOID LIPOCREAM TO PRECLUDE PERMANENT IMPAIRMENT, THE IPL PT IS HEALING WELL, AND F/U WAS DONE ON THE HAIR REMOVAL PT, BUT NO ADD'L INFO WAS PROVIDED ON THE STATUS OF THEIR CONDITION.

    Additional Manufacturer Narrative · 2

    A REVIEW OF THE REPORTED EVENT DETAILS BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT CONCLUDED THE PROBABLY ROOT CAUSE OF THE INCIDENT OCCURRING TO THE IPL PT TO BE INAPPROPRIATE SKIN TYPING BY THE DEVICE OPERATOR. ADDITIONALLY A LUMENIS MEDICAL MATTERY EXPERT CONCLUDED THAT A TEST PATCH WAS NOT COMPLETED ON THE AREA BEING TREATED IN CONTRAINDICATION TO DFU. REASONABLE ATTEMPTS WERE MADE TO CONTACT THE USER FACILITY FOR ADD'L INFO REGARDING THE HAIR REMOVAL PT, HOWEVER NON WAS PROVIDED. SHOULD ADD'L INFO BE REPORTED, A F/U MDR WILL BE FILED. AN EVAL OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL SPECIALIST CONFIRMED THAT THERE WAS NO RELATED DEVICE MALFUNCTION, AND THE DEVICE PERFORMED WITHIN ACCEPTABLE PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 2

    IT WAS REPORTED THAT ONE PT SUSTAINED HYPOPIGMENTATION TO THE FACE AFTER IPL TREATMENT WITH A LUMENIS ONE LASER AND ONE PT SUSTAINED BLISTERS TO THE BACK AFTER LASER HAIR REMOVAL TREATMENT WITH A LUMENIS ONE LASER, LIGHTSHEER HEAD. IT WAS FURTHER REPORTED THAT BOTH PATIENT WERE GIVEN LICOID LIPOCREAM TO PRECLUDE PERMANENT IMPAIRMENT, THE IPL PT IS HEALING WELL, AND F/U WAS DONT ON THE HAIR REMOVAL PT BUT NO ADD'L INFO WAS PROVIDED ON THE STATUS OF THEIR CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMENIS ONE INTENSE PULSE LIGHT DELIVERY DEVICE GEX LUMENIS LTD. YOKNEAM IPL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other
    2 NA