MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC MOUTH MIRROR

Model Number	MIR5DS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the event was not returned for evaluation.Without a returned device, a root cause could not be determined.The user facility was provided a replacement mouth mirror.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that during dental procedures patients obtained a small cut in their mouth when the mouth mirror was removed.No medical treatment sought or administered.

• Brand Name: MOUTH MIRROR
• Common Device Name: MIRROR
• 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: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 15950513
• Report Number: 1416605-2022-00010
• Device Sequence Number: 7426624
• Product Code: EAX
• UDI-Device Identifier: 10889950015527
• UDI-Public: 10889950015527
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022

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: MIR5DS
• Device Catalogue Number: MIR5DS/6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2022
• Supplement Date Received by Manufacturer: 11/13/2022
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown