MAUDE Adverse Event Report: CUTERA, INC. LASER GENESIS ; POWERED, LASER SURGICAL INSTRUMENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Scarring (2061); Skin Irritation (2076); Swelling (2091); Skin Inflammation (2443)

Event Date 03/04/2019

Event Type  Injury  

Event Description

Went to (b)(6) for cutera laser genesis to help with rosacea.Asked the dr if there were any side effects, as i had read horror stories online about fat loss and textural changes.She assured me there were absolutely no side effects.After first treatment, face dried up and broke out in cystic acne.Went for f/u where dr seemed irritated and told me laser does not cause any side effects.A couple days after f/u, noticed fat loss in right cheek.Went in for another f/u where dr seemed irritated and said it was not laser and convinced me to do another laser genesis tx, and also a voluma filler to get rid of fat loss.Did second treatment and filler, and fat loss continued, along with race car-track scars on cheeks and extremely enlarged pores.Also, after filler tx, right cheek became infected due to dr being rough from being irritated during tx because on previous f/u mentioned a dr in (b)(6) and gave name so she could view, stating clearly on website that yag lasers can and will cause fat loss if not used properly.During filler tx, she was extremely defensive and irritated, and stated she looked up dr's website and it was yag lasers for body he was talking about, not face.After i left, checked website, and it clearly states facial yag lasers.Wanted before and after pics, and had to practically beg to get them shown to me, and when i did by the dr, she used the pics of my face swollen from infection caused by filler as my after pics to show how my face was not losing fat.A few weeks after f/u, called (b)(6) demanding all of my pics.Finally, after much resistance, was able to have them uploaded to phone.That was how i was able to tell she used swollen, infected face as after pics.Ironically, all pics in between first laser treatment and swollen pics from filler were missing, which would show the obvious fat loss.Also, all of my f/u visit notes were missing from my medical records, and during all treatment visit notes, it states that i was happy with all results, which i clearly was not and stress to the dr on multiple visits, as well as various staff members.This spa should be shut down.Fda safety report id# (b)(4).

• Brand Name: LASER GENESIS
• Type of Device: POWERED, LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): CUTERA, INC.
• MDR Report Key: 8906414
• MDR Text Key: 154920614
• Report Number: MW5089118
• Device Sequence Number: 2
• Product Code: GEX
• Combination Product (y/n): N
• 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: 08/14/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 57