BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT

    MDR report key: 5844016 · Received August 3, 2016

    Report

    Report Number
    3004167969-2013-00003
    Event Type
    Injury
    Date Received
    August 3, 2016
    Date of Event
    November 9, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ALMA LASERS LTD
    Product Code
    GEI
    PMA / PMN Number
    K121150
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THIS IS A RESUBMISSION OF A PREVIOUSLY SUBMITTED MDR IN 2013. PLEASE SEE SUBMISSION COMMENT FOR EXPLANATION. EXEMPTION LETTER E2013012. ALMA LTD. (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4), (IMPORTER) INITIALLY ALMA LASERS LTD DECIDED NOT TO REPORT THE EVENT BASED ON EXPERT CLINICAL EVALUATION LISTED. IT WAS THOUGHT THAT THE REPORTED BURN DOES NOT MEET THE DEFINITION OF SERIOUS INJURY AS IT WAS EVALUATED TO BE FIRST/SUPERFICIAL SECOND DEGREE BURN. HOWEVER BECAUSE THE CLINICAL EVALUATION REQUIRED A FOLLOW-UP AND THE PATIENT DID NOT SHOW UP FOR POST-OPERATIONAL FOLLOW-UPS FDA ADVISED ALMA TO RECONSIDER ITS REPORTABLE NATURE. PURSUANT TO THAT IN ALL GOOD FAITH THE EVENT FILE WAS RE-OPENED AND ATTEMPT(S) WERE MADE TO OBTAIN ADDITIONAL INFORMATION ON 07/18/2013 VIA A PHONE CALL THAT WENT TO VOICEMAIL. THE CALL WAS RETURNED ON 02/19/2013 AND IT WAS REPORTED THAT THE PATIENT NEVER SHOWED UP FOR A FOLLOW-UP AND THE DOCTOR'S OFFICE HAD NO ADDITIONAL INFORMATION TO PROVIDE. ANOTHER ATTEMPT WAS MADE ON 04/04/2013 BUT NO FURTHER UPDATES WERE AVAILABLE ON THE MEDICAL CONDITION OF THE PATIENT AS THE PATIENT NEVER CAME BACK TO THE DOCTOR'S OFFICE. ALMA LTD IS FILING THIS REPORT TO COMPLY WITH FDA'S ADVISE SENT ON 08/28/2013 TO ALMA'S RESPONSE FOR WARNING LETTER. FOR OUR INTERNAL RECORDS THIS EVENT FILE IS NOW CLOSED ON ACCOUNT OF NO POSSIBLE FOLLOW-UP ON MEDICAL CONDITION OF THE PATIENT DUE TO LACK OF PATIENT'S COOPERATION. SHOULD ANY ADDITIONAL INFORMATION BE AVAILABLE ALMA LTD WILL RE-OPEN THE EVENT FILE AND SUBMIT A FOLLOW-UP REPOT(S) WITH FDA PER TIME LINES PUBLISHED FOR SUCH REPORTING. THE SUBJECT DEVICE WAS NOT RETURNED TO MANUFACTURER AS IT HAD BEEN USED ON OTHER OUTPATIENTS PREVIOUSLY IN THE SAME SPA WITH NO APPARENT PROBLEMS. ALSO BASED ON EVALUATION BELOW THE MOST LIKELY CAUSE OF THE EVENT WAS OPERATIONAL ERROR. THE REPORTED BURN IS MOST LIKELY TO BE CAUSED BY LASER INDUCED LIPOSUCTION PROCEDURE (DEEP LAYER OF THE SKIN) AND NOT RELATED TO THE TREATMENT DONE RIGHT AFTER WITH RF PIXEL MODALITY (SUPERFICIAL LAYER OF THE SKIN). SUCH IMMEDIATE POST-OPERATIONAL TREATMENTS ARE NOT RECOMMENDED. ALSO THE DEVICE USED FOR LIPOSUCTION WAS NOT ALMA'S DEVICE. TREATMENT PARAMETERS USED FOR PIXEL RF AS LISTED, WERE NOT WITHIN RECOMMENDED RANGE PER THE CLINICAL GUIDELINES. NO SPOT TEST WAS PERFORMED TO OBSERVE THE PATIENT'S REACTION. A LETTER HAS BEEN SENT TO (B)(4) ON 07/31/2013 AS A GENTLE REMINDER OF THE SAFETY RECOMMENDATIONS INCLUDING BUT NOT LIMITED TO THE TREATMENT PARAMETERS AND SPOT TESTS.

    Description of Event or Problem · 0

    THE SUBJECT DEVICE WAS USED TO PERFORM PIXEL RF PROCEDURE ON THE PATIENT'S ABDOMEN IMMEDIATELY AFTER ABDOMINAL TUMESCENT LASER LIPOSUCTION PROCEDURE (DEVICE USED FOR LIPOSUCTION WAS MANUFACTURED BY ANOTHER FIRM). A FULL THICKNESS BURN WAS ALLEGEDLY REPORTED ON THE LOWER ABDOMEN THAT WAS LATER CLINICALLY EVALUATED TO BE REVERSIBLE FIRST DEGREE/SUPERFICIAL SECOND DEGREE BURN. TREATMENT PARAMETERS AND NOTES: PATIENT HAD SKIN TYPE I. RF PIXEL SETTINGS WERE ONE HORIZONTAL PASS AT 100WATTS AND ONE VERTICAL PASS AT 80 WATTS. NO SPOT TEST WAS PERFORMED ON THE PATIENT TO OBSERVE PATIENT'S REACTION. (B)(4) WAS APPLIED LIBERALLY THROUGHOUT THE DAY WHEN PROCEDURE WAS PERFORMED AND PLASTIC WRAP APPLIED OVER TREATED AREA TO PREVENT BANDAGES AND COMPRESSION GARMENT FROM RUBBING OFF (B)(4). THIS TREATMENT WAS TO BE USED FOR ONE WEEK AND THE PATIENT WAS SCHEDULED FOR POST-OPERATIONAL VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496071 ACCENT RF GEI ALMA LASERS LTD RF PIXEL

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other