MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC HU-FRIEDY; SCALER

Model Number	SCNEVI4XE2
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.Lot number was not provided.
Event or Problem Description
User reported that there was a piece of metal sticking out of the scaler handle.Metal poked through user's gloves.

• Brand Name: HU-FRIEDY
• Common Device Name: SCALER
• 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: 23933703
• Report Number: 1416605-2025-00009
• Device Sequence Number: 5609665
• Product Code: EMN
• UDI-Device Identifier: 10889950127237
• UDI-Public: (01)10889950127237
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

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: Other
• Device Model Number: SCNEVI4XE2
• Device Catalogue Number: SCNEVI4XE2
• 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: 12/04/2025
• Initial Report FDA Received Date: 12/31/2025
• 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: Female