MAUDE Adverse Event Report: EVE ERNST ETTER MP3S MULTI FL 10MM MP3 FEATHER; POLISHER

Catalog Number	5030964U0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
While removing ortho buttons, a dark purple mp3 polisher cut the patient's lip and cheek.The patient was sent to an oral surgeon for stitches.The doctor was using the polisher with an air driven slow speed (controlled by foot pedal), faster than 7k speed.

• Brand Name: MP3S MULTI FL 10MM MP3 FEATHER
• Common Device Name: POLISHER
• Manufacturer (Section D): EVE ERNST ETTER; eve ernst etter; 75210 keltern germany; GM
• MDR Report Key: 19608172
• Report Number: 1032227-2024-00004
• Device Sequence Number: 15484167
• Product Code: EHL
• UDI-Device Identifier: 00887919966791
• UDI-Public: 00887919966791
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/24/2024
• Report Date (Section F): 06/24/2024

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 Catalogue Number: 5030964U0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/20/2024
• Event Location: Other
• Date Report to Manufacturer: 06/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Date Report Sent to FDA: 06/24/2024