BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA MOTUS AY

    MDR report key: 8346998 · Received February 18, 2019

    Report

    Report Number
    3001431138-2019-00003
    Event Type
    Injury
    Date Received
    February 18, 2019
    Date of Event
    January 16, 2019
    Report Date
    February 15, 2019
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K181486
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE TECHNICAL EVALUATION OF THE DEVICE WAS PERFORMED BY AUTHORIZED LOCAL SERVICE. THE DEVICE, PRIOR TO ANY INTERVENTION WAS FOUND CORRECTLY WORKING WITHIN THE SPECIFICATIONS ((B)(4) REPORT PERFORMED IN DATE FEBRUARY THE 2ND, 2019). UP TO DATE, NO ADDITIONAL INFORMATION RELATED TO THE PATIENT ARE AVAILABLE. ANYWAY IS CLEAR THAT THE TREATMENT WAS PERFORMED WITH TOO MUCH AGGRESSIVE PARAMETERS IN REFERENCE TO THE SKIN TYPE OF THE PATIENT AS DEFINED IN THE CLINICAL MANUAL CODE 055-0182-20-020 REV 1.2 AT CHAPTER 3.3.4.2 MOVEO PROTOCOL'. THE ACTUAL DEVICE INVOLVED IN THIS EVENT HAS BEEN EVALUATED AND FOUND WORKING PROPERLY WITHIN SPECIFICATIONS. THE INVESTIGATION CARRIED OUT DID NOT CONCLUDE THAT A DESIGN DEFICIENCY OR DEVICE MALFUNCTIONING WAS RESPONSIBLE FOR CAUSING THE EVENT. WITH THE LIMITED INFORMATION AVAILABLE, WE ARE UNABLE TO DETERMINE A CONCLUSION FOR THIS EVENT. DEVICE WORKING WITHIN SPECIFICATIONS. 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

    IN DATE (B)(6) 2018, MS (B)(4) SENT A COMMUNICATION TO EL.EN., RELATIVE TO AN ADVERSE EVENT IN WHICH THE PATIENT REPORTED BURNS IN THE ABDOMEN AND ARMPIT AREA FOLLOWING A HAIR REMOVAL TREATMENT WITH THE MOTUS AY LASER MEDICAL DEVICE (REF: M115A1 - S/N: (B)(4)). THIS MODEL IS NOT MARKETED IN THE USA BUT A SIMILAR DEVICE, REF M115B1 IS SOLD IN THE USA WITH 510(K) NUMBER K181486. THE COMMUNICATION REPORTED, MOREOVER, THAT THE PATIENT WAS A SKIN TYPE 5 (FITZPATRICK SCALE) AND WAS SUPPORTED WITH IMAGES OF THE TREATED AREA. BY THE IMAGES IS EVIDENT THAT THE AREA TREATED PRESENTS SCABS. IMAGES OF THE PATIENT 5 DAYS FOLLOWING THE EVENT PRESENTS THAT THE SCABS AND BURNS WERE HEALING GOOD. ALL THE INFORMATION WERE REPORTED TO THE DISTRIBUTOR BY THE TRAINING MANAGER OF THE SITE ((B)(6)). THE DISTRIBUTOR REPORTED A DECLARATION FROM THE SITE IN WHICH ARE STATED THE PARAMETER USED FOR THE TREATMENT THAT ARE: SPOT SIZE: 20MM (MOVEO); FREQUENCY: 3.5 HZ; INTENSITY: HIGH; TOTAL ENERGY DELIVERED: 1000J; FLUENCE: 7J/CM2. BASED ON THE DECLARATION FROM THE SITE THE PATIENT SUFFERS OF INGROWN HAIR. ANYWAY THE TREATMENT PARAMETERS WERE EVALUATED AND FOUND THAT THOSE ARE TOO MUCH AGGRESSIVE RELATED TO THE SKIN TYPE OF THE PATIENT. IN FACT THE CLINICAL MANUAL SUGGEST THAT FLUENCES NOT HIGHER THAN 5J/CM2 AND INTENSITY SET TO SOFT. THIS CASE HAS BEEN EVALUATED AS REPORTABLE BECAUSE THE LESION REPORTED BY THE PATIENT CAN BE CONSIDERED AS A SERIOUS INJURY (ON THE SIDE OF CAUTION BASED ONLY ON THE IMAGES PROVIDED). WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON JANUARY THE 23RD, "20189" BY EMAIL FROM THE (B)(4) DISTRIBUTOR AND, ACCORDING TO 21 CFR PART 803, SUBMITTED TO FDA AN OWN MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140778 DEKA MOTUS AY DEKA MOTUS AY GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M115A1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other