MAUDE Adverse Event Report: ACCLARO CORPORATION ULTRACLEAR; FRACTIONAL LASER

Model Number	AS-WT-00055
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Acclaro became aware that the device was used off-label in parameters that are not suitable for the modality that the dr.Utilized on his patient.During the healing process the patient developed a local infection that the physician felt important to resolve.Patient has fully healed.

• Brand Name: ULTRACLEAR
• Common Device Name: FRACTIONAL LASER
• Manufacturer (Section D): ACCLARO CORPORATION; 333 george washinton 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 ; 4015312261
• MDR Report Key: 17995836
• Report Number: 3021550489-2023-00001
• Device Sequence Number: 6670056
• Product Code: GEX
• UDI-Device Identifier: 00850039149016
• UDI-Public: (01)00850039149016(11)220706
• 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: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2023

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-WT-00055
• Device Catalogue Number: AS-WT-00055
• Device Lot Number: N/A
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female