BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDART

    MDR report key: 2677778 · Received July 18, 2012

    Report

    Report Number
    8021543-2012-04403
    Event Type
    Other
    Date Received
    July 18, 2012
    Date of Event
    October 28, 2009
    Report Date
    June 6, 2012
    Manufacturer
    MEDART A/S
    Product Code
    GEX
    PMA / PMN Number
    083123
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SERVICE 3043 FOR LASER SYSTEM 10/20/2010. BOTH PRODUCTS WERE FOUND TO BE FUNCTIONING 100% ACCORDING TO SPECS, AND WERE FIT FOR PURPOSE. MEDART WERE INFORMED 16 MONTHS AFTER THE ACTUAL PROCEDURE. MEDART WERE TRYING TO COLLECT ALL RELEVANT DATA. THIS WAS VERY DIFFICULT: 6 MONTHS AFTER THE INITIAL INFORMATION TO MEDART, THE CASE WERE CLOSED AT MEDART, AS THE THIRD-PARTY DOCTOR (B)(4) CONCLUDED THE PROBLEM BEING DUE TO THE ACTUAL HANDLING OF THE SCANNER DURING THE PROCEDURE. (B)(6) HAS BEEN INSTRUCTED TO FOLLOW THE RECOMMENDATIONS IN THE LABELING FOR THE DEVICES. WE HAVE NOT BEFORE OR AFTER THIS CASE HAD ANY EVENTS OF THE SAME KIND. (B)(4).

    Description of Event or Problem · 1

    PT CLAIM TO HAVE RECEIVED SCARRING AFTER PROCEDURE WITH CO2 LASER FOR RE-SURFACING. THE SCARRING IS FORMED AS STRIPES ON THE CHEEK. THE PT WAS AFTER THE EVENT INSPECTED BY AN INDEPENDENT DOCTOR. THE FIRST CONCLUSION WAS THAT THE STRIPED SCARRING OCCURRED DUE TO THE LASER PROCEDURE. LATER THE CONCLUSION WERE ADJUSTED TO INDICATE A COMBINATION OF HANDLING THE PRODUCT, AND USING ONLY ONE PASS. IN THE LABELING OF THE PRODUCT, IT IS RECOMMENDED TO ENSURE NO OVERLAPPING AND TO USE MORE PASSES IN ORDER TO AVOID SCARRING. THIS RECOMMENDATION WERE NOT FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDART MEDART 610 WITH MEDART 457 GEX MEDART A/S 610.000 + 457.000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention