MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC HU-FRIEDY; 10 UNIVERSAL SWIVEL, 30K

Model Number	UI30SS10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was sent in as a heating up service repair on 9/24/2024.After running a test on the insert, the insert ran normally.It was suggested to run the insert with some water to avoid overheating.The adverse event was then reported to hu-friedy on 10/4/2024.
Event or Problem Description
User facility reported that the device burned the patient's lip.No medical intervention was required.

• Brand Name: HU-FRIEDY
• Common Device Name: 10 UNIVERSAL SWIVEL, 30K
• 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 ; 1666 e. touhy ave.; des plaines, IL 60018 ; 8472574500
• MDR Report Key: 20407362
• Report Number: 1416605-2024-00011
• Device Sequence Number: 17778622
• Product Code: ELC
• UDI-Device Identifier: 10889950075767
• UDI-Public: (01)10889950075767
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K012060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

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: UI30SS10
• Device Catalogue Number: UI30SS10
• Device Lot Number: 0524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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: Other
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White