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

Model Number MAXIMA ELITE 2 CA

Device Problems Use of Device Problem (1670); Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 06/26/2023

Event Type  Injury  

Event Description

After several uses, the product heated up and burned three (3) patients.

• Brand Name: MAXIMA ELITE
• Type of Device: HANDPIECE
• Manufacturer (Section D): W&H DENTALWERK; ignaz-glaser-strasse 53; 5111 bürmoos; AU
• MDR Report Key: 17405948
• MDR Text Key: 319860533
• Report Number: 3007007357-2023-00006
• Device Sequence Number: 1
• Product Code: EFB
• UDI-Device Identifier: 00304040153857
• UDI-Public: 0100304040153857
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/27/2023,07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Report Sent to FDA: 07/27/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male