MAUDE Adverse Event Report: ACCLARO CORPORATION ULTRACLEAR; FRACTIONAL MID-IR LASER

Model Number	AS-BB-00055
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Infection (2447)
Date of Event	02/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Poor healing on the patients neck after ultraclear ablative laser treatment.Led to an infection that required prescription treatment.

• Brand Name: ULTRACLEAR
• Common Device Name: FRACTIONAL MID-IR LASER
• Manufacturer (Section D): ACCLARO CORPORATION; 333 george washington hwy; smithfield RI 02917
• Manufacturer (Section G): ACCLARO CORPORATION; 333 george washington hwy; smithfield RI 02917
• Manufacturer Contact: jose valerio ; 333 george washington hwy; smithfield, RI 02917
• MDR Report Key: 22286590
• Report Number: 3021550489-2025-00001
• Device Sequence Number: 8875713
• Product Code: GEX
• UDI-Device Identifier: 00850039149009
• UDI-Public: (01)00850039149009(11)240427
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K210847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

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: Health Professional
• Device Model Number: AS-BB-00055
• Device Catalogue Number: AS-BB-00055
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female