MAUDE Adverse Event Report: ACCURE ACNE, INC. ACCURE ACNE LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Model Number	PFMS00004
Health Effect - Clinical Codes	Skin Discoloration (2074); Superficial (First Degree) Burn (2685)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024 i was acting as the installation technician for accure acne, a laser distributor for the accure laser built by quanta system.The procedure required that i test fired the laser after calibration on my arm.This was a new procedure, and the previous procedure that required testing on the technician's arm had a max of 40c.The new procedure required 45c.I took the first shot, and it came in at 50c.I took 4 more shots around my left arm for an average treatment temperature of 45c, which meant the test passed.It has been 4 months and the spot where the initial burn occurred shows a dark mark in the typical burn pattern of the accure laser.I have documented the mark and how it has changed over the past 4 months.

• Brand Name: ACCURE ACNE LASER SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ACCURE ACNE, INC.; boulder CO 80301
• MDR Report Key: 20707956
• Report Number: MW5162580
• Device Sequence Number: 14662145
• Product Code: GEX
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Voluntary
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 11/12/2024

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
• Operator of Device: Other
• Device Model Number: PFMS00004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown