MAUDE Adverse Event Report: W&H DENTALWERK MAXIMA ELITE; HANDPIECE

Model Number	MAXIMA ELITE 2 CA
Medical Device Problem Codes	Use of Device Problem (1670); Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
After several uses, the product heated up and burned three (3) patients.

• Brand Name: MAXIMA ELITE
• Common Device Name: HANDPIECE
• Manufacturer (Section D): W&H DENTALWERK; ignaz-glaser-strasse 53; 5111 bürmoos; AU
• MDR Report Key: 17405968
• Report Number: 3007007357-2023-00007
• Device Sequence Number: 7122005
• Product Code: EFB
• UDI-Device Identifier: 00304040153857
• UDI-Public: 0100304040153857
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2023
• Report Date (Section F): 07/27/2023

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: MAXIMA ELITE 2 CA
• Device Catalogue Number: 570-2660
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/27/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2023
• 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: Other
• Patient Sex: Male
• Date Report Sent to FDA: 07/27/2023