MAUDE Adverse Event Report: EL.EN. ELECTRONIC ENGINEERING SPA DEKA MOTUS AX AY LASER HAIR REMOVAL; POWERED LASER SURGICAL INSTRUMENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bruise/Contusion (1754); Pain (1994); Skin Discoloration (2074); Skin Irritation (2076); Distress (2329)

Event Date 01/04/2021

Event Type  Injury  

Event Description

I had used the yag series for a year and needed a few touch ups.This practice recommended the motus ax machine for three sessions.During the treatment, i experienced the most pain i have ever had during a laser treatment.It literally felt my skin was on fire.Little did i know, it was.I could not sit down or put my hand down for 2 hours after the procedure.I followed the doctor's instructions to apply aloe vera, but things only got worse.The following day, i had massive, raised black welts all over my body.I called the office and was told to continue with aloe vera that they have never experienced this type of scenario.They also mentioned maybe my skin was sensitive and that my darker skin may not be a good candidate for motus ax after all.Of course, this is after i was encouraged to use the product because of its nuanced technology of being well versed for all skin types and colors.Welts developed into a severe and painful sight of dark and some open bruises all around and over my bikini, perinatal, and underarm area.Not only is it unsightly and quite traumatic to see, it is painful.I couldn't be around my husband in anyway shape or form because of the visual effect of the burns and the physical pain.This has caused intense emotional distress for me and has impacted my quality of life.Fda safety report id # (b)(4).

• Brand Name: DEKA MOTUS AX AY LASER HAIR REMOVAL
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): EL.EN. ELECTRONIC ENGINEERING SPA
• MDR Report Key: 11163432
• MDR Text Key: 227033385
• Report Number: MW5098798
• Device Sequence Number: 1
• Product Code: GEX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 81