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

Model Number MCSR1500-D-INTL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 03/23/2018

Event Type  Injury  

Manufacturer Narrative

The burn paper test results have been requested yet not received.

Event Description

The patient received a full face treatment on (b)(6) 2018.During the treatment there were no errors and nothing out of the ordinary.On (b)(6) 2018 the patient noticed erythema residual scabbing.Additional information has been requested, yet not received, regarding the patient's current status.

Manufacturer Narrative

It was reported a patient experienced erythema and residual scabbing on the face post fraxel treatment.The customer reported no system errors or anything out of the ordinary occurring during treatment.System has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits.Customer can also utilize the burn paper to confirm system laser is providing correct pattern/coverage.Customer did not perform a burn paper test and no review could be performed.According to fraxel user manual (p009220-02 rev.A), prolonged redness and blistering are known possible complication of fraxel treatment.Mild-moderate transient erythema is an expected response.However, if erythema is severe or persists significantly longer than expected, re-treatment should be avoided until the condition resolves.Reaction may vary on a patient-by-patient basis.Blistering or burns may develop over the treated areas.A review of the manufacturing records showed all requirements were met.The customer reported no system errors or anything out of the ordinary during treatment.Based on the available information, prolonged redness and blistering are known possible complication of fraxel treatment.Trending will be performed to monitor this issue.No further action is required at this time.

• Brand Name: FRAXEL RE:STORE LASER SYSTEM
• Type of Device: POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM
• Manufacturer (Section D): SOLTA MEDICAL, INC.; 11720 north creek pkwy n suite; bothell WA 98011
• MDR Report Key: 7486364
• MDR Text Key: 107327348
• Report Number: 3011423170-2018-00036
• Device Sequence Number: 1
• Product Code: ONG
• Combination Product (y/n): N
• PMA/PMN Number: K091420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MCSR1500-D-INTL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other