MAUDE Adverse Event Report: SOLTA MEDICAL FRAXEL RE:STORE LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM

Device Problem Insufficient Information (3190)

Patient Problem Skin Discoloration (2074)

Event Date 03/18/2020

Event Type  Injury  

Manufacturer Narrative

A review of the device history records is in progress.The system has no system/data logs that can be reviewed, and therefore will not be returned for evaluation.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A physician's office reported that after performing a fraxel treatment, the patient experienced hyperpigmentation.The fraxel treatment was composed of 1550nm and 1927nm passes.The 1550nm portion included four passes and four percent coverage at 25mj.The 1927nm portion included four passes and two percent coverage at 20mj.There was no overlapping of passes, and nothing unusual was noted during the treatment.Two weeks post treatment, the patient reported dark streaks down both cheeks.The available images were reviewed and hyperpigmented lesions were visible on both sides of the cheeks.Post-inflammatory hyperpigmentation is a known adverse event for all laser therapies.It is unknown if there will be permanent scarring.No secondary intervention was required, and the patient's current status is unknown.

Manufacturer Narrative

It was reported that no system issues or anything out of the ordinary occurred during treatment.No product returned for evaluation.Customer has not responded to multiple follow up attempts.Based on the available information, no causal factors can be determined and no conclusion can be drawn.

Manufacturer Narrative

Corrected d3 manufacturer name and address.

• Brand Name: FRAXEL RE:STORE LASER SYSTEM
• Type of Device: POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM
• Manufacturer (Section D): SOLTA MEDICAL; 11720 n creek parkway n; ste 100; bothell WA 98011
• MDR Report Key: 10063006
• MDR Text Key: 192541034
• Report Number: 3011423170-2020-00048
• Device Sequence Number: 1
• Product Code: ONG
• Combination Product (y/n): Y
• PMA/PMN Number: K091420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other