MAUDE Adverse Event Report: ACCLARO CORPORATION ULTRACLEAR; MIDIR FRACTIONAL FIBER LASER

Model Number	AS-WB-00055
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Localized Skin Lesion (4542); Skin Infection (4544)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On the seventh day after treatment, the patient reported skin lesions.Following a medical examination, a viral infection is suspected.Patient was prescribed cefixoral and diflucan to prevent infection.

• Brand Name: ULTRACLEAR
• Common Device Name: MIDIR FRACTIONAL FIBER LASER
• Manufacturer (Section D): ACCLARO CORPORATION; 333 george washington highway; smithfield RI 02917
• Manufacturer (Section G): ACCLARO CORPORATION; 333 george washington highway; smithfield RI 02917
• Manufacturer Contact: jose valerio ; 333 george washington highway; smithfield, RI 02917 ; 8888330399
• MDR Report Key: 22286658
• Report Number: 3021550489-2025-00002
• Device Sequence Number: 8922050
• Product Code: GEX
• UDI-Device Identifier: 00850039149429
• UDI-Public: (01)00850039149429(11)240426
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K233803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Remedial Action: 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-WB-00055
• Device Catalogue Number: AS-WB-00055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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: Other
• Patient Age: 67 YR
• Patient Sex: Female