MAUDE Adverse Event Report: SOLTA MEDICAL, INC FRAXEL DUAL 1550 LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Model Number SYS-SR1500-INTL

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

Patient Problem Blister (4537)

Event Date 02/17/2024

Event Type  Injury  

Event Description

A user facility reported three blisters on the right cheek 18 hours post fraxel treatment to the face for general resurfacing and the cheek for old acne scarring.The patient was treated with polysporine.The current status is reported as erythema with the possibility of atrophic scarring.An available picture was reviewed by the medical reviewer; erythema and a scar were visible on the cheek.It is unclear if the scar is related to this treatment or before this treatment.The provider reported they believe that the used numbing cream may be the variable causing this adverse event.It was reported that no other treatments were being performed in the same area where symptoms were reported.The patient underwent dermaplaning facial about four months ago.Previous aesthetic treatments in this area include the following: facials, chemical peels, microneedling, laser genesis, fraxel, and co2 laser.Prior to treatment, patient was using the following skin care products: la roche posay toleriane dermo-cleanser, la roche posay dermallergo cream, la roche posay cicaplast, vivier sheer, and spf 45.Polysporin was added during treatment, and vivier v-stat once the blisters were closed up.No sun exposure was reported during healing as the patient wore face shields and hats when driving.The patient''s skin type was reported as, fitz i; fair skin, red hair, hazel eyes.An 1550 nm wavelength was used to perform treatment, with the highest energy used as 50mj, tx #10/29%, 8 passes.Overlapping passes consisted of, vertical x 2, horizontal x 2, repeat for total of 8 as per protocol.It is unknown what rep the incident occurred at.No system errors occurred nor was anything out of the ordinary noticed during treatment.The individual tip has been used at least once without any incidents occurring.

Manufacturer Narrative

The fraxel treatment tips do not delivery any energy and no treatment data is stored on the tip itself; there is no information to gather from their return.The exception to this would be if the fraxel tip plastic housing or component scratched the patient.For other reported events, tips are not a viable source of evaluation data.The system has no system/data logs that can be reviewed.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should the system be outside of acceptable limits.The customer can also utilize the burn paper to confirm the system laser is providing correct pattern/coverage.The customer performed the burn paper test and review showed proper pattern/coverage.Product evaluation did not confirm the failure mode.The customer was advised to make certain that the hand piece, snout, lens, and tip are always cleaned prior to each use, and cleaned after each treatment as well.According to fraxel dual 1550/1927 laser system user manual, burns and blisters are known possible complication after fraxel treatment.Blistering or burns may develop over the treated areas.No non-conformities or anomalies found related to this complaint when reviewing the device history record.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.This event is most likely unrelated to the device.Based off the available information, burns and blisters are known possible complication after fraxel treatment.No corrective action is necessary.

Manufacturer Narrative

This event no longer meets reportability requirements as no serious injury occurred.The conclusions of the previous report remain unchanged.

Event Description

Additional information has been received indicating that the patient is "good again (healed)" and the event is resolved.The information provided does not suggest this incident may have caused or contributed to a death, serious injury or a serious deterioration in state of health.This event no longer meets reportability requirements.

• Brand Name: FRAXEL DUAL 1550 LASER SYSTEM
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 n creek pkwy n; ste 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC; 11720 n creek pkwy n; ste. 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste. 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 18997226
• MDR Text Key: 338885759
• Report Number: 3011423170-2024-00136
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00816995027263
• UDI-Public: 00816995027263
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K130193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

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
• Device Model Number: SYS-SR1500-INTL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1