MAUDE Adverse Event Report: W&H DENTALWERK HENRY SCHEIN; HANDPIECE

Model Number	MAXIMA ELITE 2 CA
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Device was over heating during treatment of patient.No injuries or burns reported.

• Brand Name: HENRY SCHEIN
• Common Device Name: HANDPIECE
• Manufacturer (Section D): W&H DENTALWERK; ignaz-glaser-strasse 53; bürmoos, 5111 ; AU 5111
• MDR Report Key: 20676070
• Report Number: 3007007357-2024-00032
• Device Sequence Number: 8949297
• Product Code: EFB
• UDI-Device Identifier: 00304040153857
• UDI-Public: (01)00304040153857
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/12/2024
• Report Date (Section F): 11/14/2024

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: MAXIMA ELITE 2 CA
• Device Catalogue Number: 570-2660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2024
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/16/2024
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2024
• 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: Other
• Patient Sex: Female
• Date Report Sent to FDA: 11/14/2024