MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC IMS; PARTS BOX - LARGE

Model Number	IMS-1273
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The open parts box was not found to have any chips or burrs.Some of the corners are not rounded, especially on the lid.The cut was suspected to be akin to a paper cut.An analysis of returns showed no returns for cut or sharp edges in the past 5 years.
Event or Problem Description
Customer reported that when the doctor opened a box of the product there was something sharp on the cassette and it cut her hand.

• Brand Name: IMS
• Common Device Name: PARTS BOX - LARGE
• 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: 24019722
• Report Number: 1416605-2025-00016
• Device Sequence Number: 10545647
• Product Code: FSM
• UDI-Device Identifier: 10889950036409
• UDI-Public: (01)10889950036409
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K844002
• 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): 01/09/2026

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: IMS-1273
• Device Catalogue Number: IMS-1273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female