BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA MOTUS AX

    MDR report key: 11299914 · Received February 9, 2021

    Report

    Report Number
    3001431138-2021-00001
    Event Type
    Injury
    Date Received
    February 9, 2021
    Date of Event
    January 4, 2021
    Report Date
    May 4, 2021
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    UDI-DI
    08057017760221
    PMA / PMN Number
    K162886
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE, THE MANUFACTURER OF THE DEVICE, BASED ON THE INFORMATION REPORTED ON THE MW REPORT MW5098798 ATTEMPTED TO GATHER ADDITIONAL INFORMATION. ANYWAY NO ADDITIONAL INFORMATION HAS BEEN DISCLOSED AND NO FURTHER INVESTIGATION HAS BEEN POSSIBLE. BASED ON THAT THE INVESTIGATION WAS INCONCLUSIVE AND THE CONCLUSION HAS NOT CHANGED SINCE OUR INITIAL MDR 3001431138-2021-00001. THE PRESENT FOLLOW-UP REPORT HAS BEEN PREPARED AS AN OFFICIAL REPLY TO THE MW5098789. THIS REPORT HAS TO BE CONSIDERED AS FINAL UNLESS FDA HAVE FURTHER QUESTION.

    Description of Event or Problem · 0

    ON (B)(6) 2021, EL.EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE US AGENT EMERGO. IN THE US AGENT'S COMMUNICATION IT IS REPORTED THE MEDWATCH REPORT SUBMITTED BY THE PATIENT TO THE FDA CODE MW5098798 IN WHICH THE PATIENT COMPLAINTS TO HAVE SUFFERED BURNS FOLLOWING A LASER TREATMENT WITH THE MEDICAL DEVICE MOTUS AX, WITH THE ND:YAG LASER SOURCE. BASED ON THE INFORMATION REPORTED ON THE MEDWATCH REPORT MW5098798 WE, THE MANUFACTURER OF THE DEVICE, PERFORMED AN INITIAL INVESTIGATION AND FOUND OUT THAT THE SAME EVENT HAS ALREADY BEEN NOTIFIED TO EL.EN. SPA BY THE SAME PATIENT ON (B)(6) 2021 AND FOR WHICH WE ALREADY SUBMITTED AN MDR REPORT TO THE FDA MDR3001431138-2021-00001 ON FEBRUARY THE 9TH, 2021. THIS CONCLUSION HAS BEEN MADE BECAUSE THE NAME OF THE PATIENT AND THE TIME OF THE EVENT CORRESPONDS AS WELL AS THE WORDING USED FOR THE INITIAL COMMUNICATION TO EL.EN. AND IN THE MW REPORT. IN ACCORDANCE TO THE 21 CFR PART 803.22(A), DUE TO THE FACT THAT WE RECEIVED INFORMATION FROM DIFFERENT SOURCES, BUT RELATIVE TO THE SAME REPORTABLE EVENT, WE PROCEEDED TO FOLLOW-UP ON THE REPORT ALREADY SUBMITTED TO THE FDA FOR THIS EVENT. WE, THE MANUFACTURER OF THE DEVICE, BECAME AWARE OF THE EVENT ON (B)(6) 2021 VIA EMAIL FROM OUR US AGENT AND PROCEEDED TO SUBMIT THE PRESENT MDR REPORT TO FORMALLY REPLY THE MW REPORT MW5098798.

    Additional Manufacturer Narrative · 1

    WE, THE MANUFACTUERE OF THE DEVICE, AND OUR US IMPORTER PERFORMED OUR INVESTIGATION BY CONTACTING THE PATIENT AND THE SITE IN ORDER TO GATHER MORE DETAILED INFORMATION ON THE EVENT. THE US IMPORTER FOUND THE ACTUAL DEVICE INVOLVED IN THE EVENT AND THE EXACT CLINIC WHERE THE TREATMENT WAS PERFORMED (NOT SPECIFIED IN THE INITIAL COMMUNICATION BY THE PATIENT): THE ACTUAL DEVICE INVOLVED IN THE EVENT IS MOTUS AX LASER MEDICAL DEVICE (REF: (B)(4) S/N: (B)(4)). BASED ON THE INFORMATION COLLECTED ON OUR DATABASES THE DEVICE IS INSTALLED AT (B)(6) USA. CARTESSA AESTHETICS PERFORMED SEVERAL ATTEMPTS TO CONTACT, VIA PHONE AND EMAIL, BOTH THE PATIENT AND THE SITE. THE PATIENT WAS UNRESPONSIVE WHILE THE CLINIC NEVER ANSWERED TO SEVERAL MESSAGE LEFT TO THE RECEPTIONIST. DUE TO THE FACT THAT BOTH PATIENT AND CLINIC WERE UNRESPONSIVE IT WAS IMPOSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT AND TO DETERMINE IF THE DEVICE HAS GOT ANY MALFUNCTION. IN FACT THE SITE NEVER ANSWERED BACK TO OUR REQUEST OF APPOINTMENT TO INSPECT THE DEVICE. IN THE LIGHT OF THE ATTEMPTS PERFORMED TO CONTACT BOTH PATIENT AND CLINIC WE ASSUMED TO HAVE PERFORMED A GOOD FAITHFUL EFFORT TO PROPERLY INVESTIGATE ON THE PROCEDURE, THE ACTUAL STATE OF HEALTH OF THE PATIENT AND THE ACTUAL DEVICE INVOLVED IN THE EVENT. BASED ON THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DETERMINE THAT THE DEVICE CONTRIBUTED TO THE PATIENT'S SYMPTOMS. THE INVESTIGATION CARRIED OUT BASED ONLY ON THE LIMITED INFORMATION MADE US IMPOSSIBLE TO DETERMINE THE EXACT CONCLUSION FOR THIS EVENT. NO REMEDIAL ACTION REQUIRED. IN CASE OF NEW INFORMATION WILL BE MADE AVAILABLE FOR THIS CASE A FOLLOW-UP TO THIS REPORT WILL BE SUBMITTED IN A TIMELY MANNER. THIS INITIAL REPORT IS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2021, EL.EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE PATIENT VIA EMAIL, CONCERNING AN ADVERSE EVENT HAPPENED TO HER FOLLOWING A HAIR REMOVAL TREATMENT WITH MOTUS AX LASER MEDICAL DEVICE AND ND:YAG LASER SOURCE. THE PATIENT REPORTED IN HER EMAIL THAT SHE HAS RECENTLY GOT ( WITHOUT SPECIFYING THE EXACT DATE OF THE EVENT) A HAIR REMOVAL TREATMENT IN THE UNDERARM, BIKINI AND PERINEAL AREAS AND TO HAVE DEVELOPED BURNS. THE PATIENT, IN HER NARRATIVE, REPORTED THAT SHE HAD ALREADY USED THE ND:YAG LASER FOR A YEAR, AND NEEDED A FEW TOUCH-UPS. THE CLINIC PRACTITIONER SUGGESTED THE PATIENT A CYCLE OF 3 TREATMENTS WITH THE MOTUS AX. DURING THE TREATMENT (NOT SPECIFIED WHICH ONE OF THE THREE SCHEDULED) THE PATIENT EXPERIENCED STRONG PAIN AND BURNING SENSATION. FOR THE FOLLOWING TWO HOURS, POST TREATMENT, SHE WAS UNABLE TO PROPERLY SIT AND WALK. THE PRACTITIONER AND THE NURSE WHO ACTUALLY PERFORMED THE TREATMENT, RECOMMENDED THE PATIENT TO APPLY ALOE VERA ON THE AREA. DESPITE THE ALOE VERA THE FOLLOWING DAY THE PATIENT DEVELOPED BLACK WELTS IN THE TREATED AREA. IN THE FOLLOWING DAYS THE PATIENT DEVELOPED PAINFUL BLISTERS IN THE TREATED AREA. THE PATIENT CONCLUDED THAT THIS EVENT CAUSED AN INTENSE EMOTIONAL DISTRESS TO HER AND IMPACTED HER QUALITY OF LIFE. WE, THE MANUFACTURER OF THE DEVICE, REQUESTED THE COOPERATION OF OUR US IMPORTER CARTESSA AESTHETICS, A COMPANY LOCATED IN (B)(6) US, FOR THE INVESTIGATION ON THIS CASE. CARTESSA AESTHETICS WAS INFORMED BY THE MANUFACTURER IN DATE (B)(6) 2021 AND IMMEDIATELY STARTED ITS INVESTIGATION. CARTESSA AESTHETICS ALSO REPRESENTS US DISTRIBUTOR AND SERVICE CENTER FOR EL.EN. ELECTRONIC ENGINEERING SPA MEDICAL DEVICES. WE, THE MANUFACTURER OF THE DEVICE, BECAME AWARE OF THE EVENT ON (B)(6) 2021 BY EMAIL FROM THE PATIENT AND, ACCORDING TO 21 CFR PART 803 EVALUATED THIS EVENT AS REPORTABLE DUE TO THE FACT THAT THE LESION REPORTED BY THE PATIENT ARE TO BE CONSIDERED AS SERIOUS INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198973 DEKA MOTUS AX DEKA MOTUS AX GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M112B1 08057017760221

    Patients

    Seq Age Sex Outcome Treatment
    1 Other