MAUDE Adverse Event Report: MECTRON S.P.A. HUFRIEDYGROUP; DENTAL SCALER AND AIR POLISHER

Model Number	APPAIR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Swelling/ Edema (4577)
Date of Event	05/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 80+ year old patient got an air embolism during use of the pwr pair.
Event or Problem Description
On (b)(6) 2025, we were informed by our distributor hu-friedy group that a patient of one of their customers experienced an adverse event during a treatment with the device object of the present report.From a first notice, the patient condition reported by the dentist was air embolism that occurred after scaling treatment followed by about 1 second of periodontal air polishing.The patient was sent by the dentist to the hospital after he noticed a swelling of the left side of face, eye, and neck.
Additional Manufacturer Narrative
Analysis of production records no anomalies or non-conformities emerged from the review of product release control data.Trend analysis no historical records available of similar events for this or similar product.Clinical evaluation & conclusion despite multiple follow-up attempts, the patient declined to provide further diagnostic details regarding the suspected air embolism.The only available clinical information includes reported swelling on the left side of the face, eye, and neck.Due to the lack of confirmed medical diagnosis and the absence of instrumental evidence, no definitive conclusion can be drawn regarding the nature of the adverse event.Furthermore, based on the technical evaluation and the available usage data, no causal relationship can be established between the adverse event and the medical device or its method of use.

• Brand Name: HUFRIEDYGROUP
• Common Device Name: DENTAL SCALER AND AIR POLISHER
• Manufacturer (Section D): MECTRON S.P.A.; via loreto 15/a; carasco, genoa - italy 16042 ; IT 16042
• Manufacturer (Section G): MECTRON S.P.A; via loreto 15/a; carasco, genoa - italy 16042 ; IT 16042
• Manufacturer Contact: manuela galliano ; via loreto 15/a; carasco, genoa - italy 16042 ; IT 16042
• MDR Report Key: 23355416
• Report Number: 3003933619-2025-70000
• Device Sequence Number: 8888269
• Product Code: KOJ
• UDI-Device Identifier: 10889950142551
• UDI-Public: 10889950142551
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K231391
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: APPAIR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female