MAUDE Adverse Event Report: NIRA INNOVATIONS INC NIRA PRO

Model Number	151-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Skin Discoloration (2074); Physical Asymmetry (4573)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, patient, a 76-year-old woman, experienced a severe adverse reaction upon waking up that day.She woke up to find her face significantly distorted, with lumps, dark areas, and swelling.The internal inflammation was so severe that it made flossing her teeth difficult due to the swelling inside her mouth.She had been using the nira pro device intermittently for three months.Despite her careful use, she did not notice any changes until the morning of (b)(6) 2024, when the adverse symptoms appeared suddenly.She claims that this inflammation may be the result of the nira laser use, however there was no direct connection between using the laser for many months and this particular overnight reaction.In an attempt to address the issue, she visited her dermatologist, dr.(b)(6), on (b)(6) 2024.Due to her medical history, which includes a previous perforated ulcer that prevents her from taking anti-inflammatories, she was prescribed doxycycline (100 mg, twice a day) and opzelura cream.The treatment has led to some improvement, but as of (b)(6) 2024, she still experiences some swelling and bulges on her face.

• Brand Name: NIRA PRO
• Common Device Name: NIRA PRO
• Manufacturer (Section D): NIRA INNOVATIONS INC; 42 nh-111; derry NH 03038
• Manufacturer (Section G): NIRA; 42 route 111; derry NH 03038
• Manufacturer Contact: yash morbia ; 42, route 111; derry, NH 03038
• MDR Report Key: 22208421
• Report Number: 3015109022-2025-00001
• Device Sequence Number: 7644205
• Product Code: OHS
• UDI-Device Identifier: 00850020752119
• UDI-Public: 00850020752119
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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: 151-001
• Device Lot Number: 022920241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLOOD PRESSURE MEDICATION.; CHOLESTEROL MEDICATION.; DAILY VITAMINS.; ESTROGEN.; THYROID MEDICATION.; TYLENOL EXTRA STRENGTH.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White