MAUDE Adverse Event Report: FRAXEL RESTORE; FRAXEL RESTORE LASER

Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Tissue Damage (2104); Depression (2361)

Event Date 01/24/2014

Event Type  Injury  

Event Description

I did a fraxel restore laser treatment at (b)(6) medical spa in (b)(6) on (b)(6) 2014.I did this hoping to improve the acne scars on my cheeks as the claimed in marketing materials.Very unfortunately, 2-3 months post the treatment, the acne scars didn't improve a little but i experienced dramatic facial fat and collagen loss.Followed by sinking upper eyelids, loose skin and nasolabial folds.The facial fat loss and collagen loss continued til now.I aged at least 5-8 years during the past year and this caused me very deep depression.And i noticed the accelerated aging process didn't stop til now.I did not realize all this is due to fraxel treatment until (b)(6) this year when i happened to read tons of similar complaints about facial fat loss after fraxel treatment online ((b)(6)).Victims like me have saggy skin, sinking eye lids, black circles, and nasolabial folds too.My whole face looks like a skeleton last year after the fraxel treatment.I tried to eat a lot and managed to gain almost 7 pounds since my facial fat loss started to happen last year.And now my face looks not that skinny but saggy skin, sinking eyelids and never existed before nasolabial folds are still there and are getting worse day by day.I know it's impossible to recover.I went back to complain to (b)(6) medical spa in (b)(6) this year.The spa manager, (b)(6), offered to get someone from fraxel manufacturer side (solta medical) and explain why fraxel will or will not cause all the side effects.It has been four months now and yesterday i called to check on the status of my case.I was told that they no longer can talk to patients directly and give any explanation.All they can do is to document this in the file.I am very desperate and stressed out everyday due to my appearance change during the past year.And when i look online, there are tons of other victims.Most of them experienced depression like me after the obvious appearance change.Some of them committed suicide already.I feel like i need to speak out on behalf of those victims.I sincerely hope fda could ban fraxel machine here.The complications from this machine are much more than the benefits it could bring to patients, if there is any benefit at all.I am willing to provide any proof or documents you need to do any further investigation.

• Brand Name: FRAXEL RESTORE
• Type of Device: FRAXEL RESTORE LASER
• MDR Report Key: 4758789
• MDR Text Key: 5785038
• Report Number: MW5042569
• 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: 04/24/2015

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?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2015
• Patient Sequence Number: 1
• Patient Age: 29 YR