CLEAR + BRILLIANT LASER SYSTEM CB-HP-1927

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-12 for CLEAR + BRILLIANT LASER SYSTEM CB-HP-1927 manufactured by Solta Medical Inc..

Event Text Entries

[185891872] Product will not be returned for evaluation because the clear+brilliant treatment tips do not deliver any energy and no treatment data is stored on the tip itself; there is no information to gather from their return. System has software safeguards that will trigger error/event codes should the 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 requested burn paper test and thus we cannot verify proper pattern/coverage. A review of the device history record is in progress. Based on all available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10

[185891873] A physician reported that three days after undergoing a clear + brilliant treatment the patient called to report they were experiencing redness and irritation across the chest, neck, and lower face, as well as throat swelling. The patient reported they initially observed redness, puffiness, and hives in the treatment area that progressively got worse. The patient self treated with benadryl. The patient visited the emergency room on the third day and the physician indicated an anaphylactic reaction had occurred and administered the patient an oral steroid and gave the patient an epi-pen in case of additional reaction. The physician believes that the patient experienced an allergic reaction to the topical gel applied to the patient. The patient is recovered. The patient was treated with clear + brilliant across the face and neck. No issues or errors were reported during the treatment. The patient was administered a topical anesthetic prior to treatment composed of lidocaine and tetracaine hcl liposav. The doctor reported that during treatment the highest power level used was high. The doctor noted following the treatment the patient was administered over the counter topical creams skinceuticals ce ferulic and colorscience even up spf 50 on the treatment site. It was reported that the patient has a sulfa allergy. The doctor also indicated that the patient underwent an ipl treatment for rosacea in the same area around 2 weeks prior to the clear + brilliant treatment.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3011423170-2020-00024
• MDR Report Key: 9699801
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2020-02-12
• Date of Report: 2020-02-03
• Date of Event: 2020-01-31
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-02-03
• Date Added to Maude: 2020-02-12
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. JENNIFER GAMET
• Manufacturer Street: 1400 N GOODMAN ST
• Manufacturer City: ROCHESTER NY 14609
• Manufacturer Country: US
• Manufacturer Postal: 14609
• Manufacturer Phone: 5853386853
• Manufacturer G1: SOLTA MEDICAL
• Manufacturer Street: 11720 N CREEK PARKWAY N STE 100
• Manufacturer City: BOTHELL WA 98011
• Manufacturer Country: US
• Manufacturer Postal Code: 98011
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: CLEAR + BRILLIANT LASER SYSTEM
• Generic Name: POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM
• Product Code: ONG
• Date Received: 2020-02-12
• Model Number: CB-HP-1927
• Device Availability: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SOLTA MEDICAL INC.
• Manufacturer Address: 11720 NORTH CREEK PKWY N SUITE 100 BOTHELL WA 98011 US 98011

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-02-12
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-02-12