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

Model Number	APPAIR
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The issue may be crossed air and water lines based on the description of the issue.This will cause a clog in the unit and lack of air and / or water in the line based on historical returns.Device was not returned to manufacturer.
Event or Problem Description
Dentist reported while using the pwr air polisher it was damaging the tissue on gums.

• Brand Name: PWR PAIR
• Common Device Name: AIRBRUSH
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG CO LLC; 3232 n rockwell st; chicago IL 60618
• Manufacturer Contact: stephanie wasielewski ; 3232 n rockwell st; chicago, IL 60618 ; 8472574500
• MDR Report Key: 24584082
• Report Number: 1416605-2026-00002
• Device Sequence Number: 9232919
• Product Code: KOJ
• UDI-Device Identifier: 10889950142551
• UDI-Public: (01)10889950142551
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 03/12/2026

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
• Device Catalogue Number: APPAIR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown