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

Model Number PFMS00004

Device Problems Energy Output Problem (1431); Improper or Incorrect Procedure or Method (2017); Excessive Heating (4030)

Patient Problem Scar Tissue (2060)

Event Date 07/14/2023

Event Type  Injury  

Event Description

Accure was notified by a provider that a patient exhibited scarring after treatment.At the follow up visit, about six weeks later, the patient presented with scarring.The provider has discussed a combination treatment utilizing an ablative laser and filler to treat the scarring.

Manufacturer Narrative

A service technician visited the site and found one of four treatment locations was delivering higher than expected power.The region of interest (roi) #4 was out of position and had to be corrected.Roi misalignment was caused by excessive handpiece tip movement by the user.Follow-up information indicated the provider did not use alcohol as the final step in removal of the topical anesthetic.The provider also utilized higher than recommended settings for peak epidermal temperature.The roi misalignment created a higher-than-expected power resulting in scarring.The possible incomplete removal of the topical anesthetic can be a contributing factor to localized thermal absorption of energy.

• Brand Name: ACCURE LASER SYSTEM
• Type of Device: ACNE LASER
• Manufacturer (Section D): ACCURE ACNE, INC.; 4699 nautilus court s; suite #205; boulder CO 80301
• Manufacturer (Section G): QUANTA SYSTEM SPA; via acquedotto, 109; 21017 samarate (va), ; IT
• Manufacturer Contact: jon mullen ; 4699 nautilus court s; suite #205; boulder, CO 80301 ; 6034903390
• MDR Report Key: 17821888
• MDR Text Key: 324321093
• Report Number: 3017786046-2023-00005
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222109
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PFMS00004
• Device Catalogue Number: PFMS00004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White