MAUDE Adverse Event Report: NIRA INNOVATIONS INC. NIRA INNOVATIONS INC.; NIRA PRO+

Model Number	160-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Scar Tissue (2060); Blister (4537)
Date of Event	08/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 06 august 2025, nira innovations inc.Received initial information from a consumer reporting localized facial burns and blister formation following use of the nira pro+ laser.The consumer was contacted for follow-up, advised to discontinue use, and requested to return the device for evaluation.The consumer remained in communication with the manufacturer through the investigation period and was contacted periodically for status updates.On (b)(6) 2025, during follow-up correspondence, the consumer reported that the affected area had healed with a residual scar and that a dermatologist had recommended resurfacing treatment.At that time, the manufacturer determined that the case met the definition of a serious injury (permanent impairment) under 21 cfr 803.3.The returned device underwent a investigation to verify laser output.The laser output was found to be within the specification.Following confirmation of the persistent scar and medical consultation, the event was classified as a serious injury, and this medical device report was submitted to the u.S.Fda within the required 30-day reporting period.
Event or Problem Description
On (b)(6) 2025, a consumer reported sustaining a facial burn after using the nira pro+ laser.The device was applied to the lower cheek on dry, clean skin.Shortly after use, the consumer noticed redness and a burning sensation, which progressed to blister formation within hours.The consumer discontinued further use immediately and self-treated with topical neosporin.Follow-up communication confirmed a localized burn with blister formation on the lower cheek.She was advised to discontinue use and to consult a healthcare provider or dermatologist.The device was returned on 04 sep 2025 for evaluation under the company's refund and investigation process, and nira received it on (b)(6) 2025.During follow-up, the consumer reported that the area was healing but remained discolored.On (b)(6) 2025, during a follow-up call, she reported residual scarring on the affected site and provided a note from her dermatologist recommending resurfacing treatment.Because the burn resulted in persistent scarring and required medical consultation, the manufacturer classified this event as a serious injury.

• Brand Name: NIRA INNOVATIONS INC.
• Common Device Name: NIRA PRO+
• Manufacturer (Section D): NIRA INNOVATIONS INC.; 42, route 111; derry NH
• Manufacturer (Section G): NIRA INNOVATIONS INC.; 42, route 111; derry
• Manufacturer Contact: 42, rouute 111; derry, NH
• MDR Report Key: 23922870
• Report Number: 3015109022-2025-00002
• Device Sequence Number: 9338446
• Product Code: OHS
• UDI-Device Identifier: 00850020752454
• UDI-Public: 00850020752454
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/06/2025

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: Lay User/Patient
• Device Model Number: 160-001
• Device Lot Number: 060220251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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: 35 YR
• Patient Sex: Female