MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC PWR PAIR; AIR POLISHING

Model Number	APPAIR
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
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
Reported that the patient got air embolism during air polishing treatment.Patient was sent to the hospital and stayed overnight.
Additional Manufacturer Narrative
Device is being returned to manufacturer.Manufacturer has not received device as of today.Investigation is ongoing.
Additional Manufacturer Narrative
Technical evaluation summary: on september 19th 2025, as soon as the device was returned by the customer, mectron's technical service laboratory conducted a full evaluation of the pwr pair unit serial (b)(6) and associated handpieces.The following results were obtained: · pwr pair electrical safety test: passed successfully.· pwr air perio handpiece serial (b)(6): - pressure prophy mode: 3.45 bar (reference value: 3.5 bar +/- 0.1).- pressure perio mode: 2.1 bar (reference value: 2.7 bar +/- 0.1).· pwr piezo led handpiece serial (b)(6): - arrived non-functional, showing no insert tuning and zero insulation.Evaluation: pressure perio mode deviation of pwr air perio handpiece is not consistent with the reported event.In fact, the reduced measured pressure, would reduce the risk of complications of air prophylaxis treatments.The scaler pwr piezo led handpiece condition is likely due to post-event usage or damage during transport.No other problems or mulfunctions were detectable.Clinical evaluation & conclusion: despite multiple follow-up attempts, the patient declined to provide further diagnostic details regarding the suspected airembolism.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: PWR PAIR
• Common Device Name: AIR POLISHING
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer (Section G): MECTRON S.P.A.; via loreto 15/a; carasco, gennoa 16042 ; IT 16042
• Manufacturer Contact: manuela galliano ; via loreto 15/a; carasco, genoa 16042 ; IT 16042
• MDR Report Key: 22436418
• Report Number: 1416605-2025-00007
• Device Sequence Number: 4670005
• Product Code: KOJ
• UDI-Device Identifier: 10889950142551
• UDI-Public: (01)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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: 06/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Other
• Patient Sex: Female