MAUDE Adverse Event Report: SOLTA MEDICAL, INC FRAXEL DUAL 1550/1927 LASER SYSTEM & ACCESSORIES; POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM

Model Number SYS-SR1500-D-US

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 02/23/2021

Event Type  Injury  

Manufacturer Narrative

The user facility has not responded to multiple follow up attempts.The device has not been returned for evaluation.The investigation continues to be underway.On march 25, 2021, bausch + lomb received an email from sheila connors at cdrh/food and drug administration notifying the company that the report initially submitted on 03/16/2021 failed in the emdr system with an error due to the presence of the ¿}¿ character as part of the c-code value.There was no ack3 error message which notifies the company that the submission was rejected due to the character.The special character (¿}¿) has been removed and this report is being resubmitted.

Event Description

A report of an adverse event noting blisters on the face - skin is lifted like a blister.This happened instantly and treatment was stopped at the second pass.The treatment settings were at 20mj, level 6 with 8 passes.No other information is available at this time.The case will be reassessed when and if additional information become available.

Manufacturer Narrative

The product was not returned for evaluation as the customer did not respond to multiple follow up attempts.According to fraxel laser systems operator manual (b)(4) rev.A), blistering and burns are known possible patient reactions to fraxel treatment.Blistering or burns may develop over the treated areas.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable; with the product performing within anticipated rates.No corrective action required.Based on the lack of information and no product return by customer, no causal factors can be determined and no conclusion can be drawn.

• Brand Name: FRAXEL DUAL 1550/1927 LASER SYSTEM & ACCESSORIES
• Type of Device: POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 north creek pkwy; suite 100; bothel WA 98011
• MDR Report Key: 11574976
• MDR Text Key: 243123262
• Report Number: 3011423170-2021-00029
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SYS-SR1500-D-US
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other