BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORMATK MAGMA PLATFORM LASER

    MDR report key: 9504282 · Received December 19, 2019

    Report

    Report Number
    MW5091783
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    May 22, 2016
    Report Date
    December 17, 2019
    Manufacturer
    FORMATK SYSTEMS LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    THE (B)(6) PURCHASED 6 GRADE 4 LASERS DESIGNED BY THE MFR REFERRED TO IN THIS DOCUMENT VIA ITS (B)(4) DISTRIBUTOR. ON THIS OCCASION (AND THERE WERE OTHERS) ONE OF THE LASERS CAUSED SERIOUS AND SIGNIFICANT BURNS TO THE BACK OF THE PT (B)(6). (B)(6) HAS SUCCESSFULLY SUED THE (B)(4) DISTRIBUTOR IN THE HIGH COURT IN (B)(6) AND WAS, ON (B)(6) 2019, AWARDED DAMAGES OF THE (B)(6) PLUS COSTS FOR CLAIMS / WARRANTIES MADE BY THE DISTRIBUTOR (AND THE SAME CLAIMS THAT ARE STILL BEING MADE BY THE MFR). (B)(6) WAS ABLE TO MITIGATE THE PERMANENT IMPACT OF THE BURNS TO THE PT THROUGH AN EXTENSIVE COURSE OF SKIN TREATMENTS. THE LASERS OBTAINED 510K APPROVAL FROM THE FDA ON APRIL 6, 2016 (K153566). WE DO NOT BELIEVE THAT THE MFRS HAVE MADE A DISCLOSURE TO THE FDA IN RESPECT OF THE ISSUES FACED BY (B)(6) AND ITS CLIENTS. THE CASE WAS COMPLEX BUT THE FINDINGS OF THE JUDGE CAN BE FOUND AT (B)(6). (B)(6) ENGAGED 2 EXPERTS (CLINICAL AND TECHNICAL) AS PART OF ITS LITIGATION TO ASSESS THE SAFETY AND EFFICACY OF THE LASERS. THESE EXPERTS' REPORTS CAN BE PROVIDED ON REQUEST. MAGMA LASER (510K REF K153566). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286817 FORMATK MAGMA PLATFORM LASER POWERED LASER SURGICAL INSTRUMENT GEX FORMATK SYSTEMS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R