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

Model Number	MAXIMA ELITE 2 CONTRA ANGLE
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Two female patients were burned from the maxima elite 2 contra angle on two different occasions.One time was on (b)(6) 2024 while the other was on (b)(6) 2024.One patient is 43 years old while the other is 67 years old.It is not clear which had the burn where but one was on the lip while the other was on the buccal muscosa.The type of burn was a large ulcer.Vitamin e was placed on the area for the burn and no further treatment needed.It was the head part that got hot.One patient is doing fine as of today while the other they have not seen since.Additional correspondence from the doctor was received on 12/18/2024: it was stated that both a patient and staff member received a burn from the handpiece is this correct? no, 2 patients were burned.We were also made aware that it was a male and female.Which was the patient and which was the staff member? no, 2 female patients.Could you share the age of both the patient and staff member? 43 years old and 67 years old.Where was the burn received on each? one on the lip and the other on the buccal mucosa.What type of burn was received? it was a large ulcer.What was done to treat the burn received? vitamin e was placed.What part of the contra angle got hot? the head of the contra angle.How are both people affected doing as of today? we have not seen one since, the other is doing fine.Was there any medical treatment necessary? vitamin e ointment was placed, no further treatment needed.When did this happen, do you have a specific date when? on (b)(6) 2024.
Event or Problem Description
Two female patients were burned from the maxima elite 2 contra angle on two different occasions.One time was on (b)(6) 2024 while the other was (b)(6) 2024.One patient is 43 years old while the other is 67 years old.It is not clear which had the burn where but one was on the lip while the other was on the buccal muscosa.The type of burn was a large ulcer.Vitamin e was placed on the area for the burn and no further treatment needed.It was the head part that got hot.One patient is doing fine as of today while the other they have not seen since.Additional correspondence from the doctor was received on 12/18/24: it was stated that both a patient and staff member received a burn from the handpiece is this correct? no, 2 patients were burned.We were also made aware that it was a male and female.Which was the patient and which was the staff member? no, 2 female patients.Could you share the age of both the patient and staff member? 43 years old and 67 years old.Where was the burn received on each? one on the lip and the other on the buccal mucosa.What type of burn was received? it was a large ulcer.What was done to treat the burn received? vitamin e was placed.What part of the contra angle got hot? the head of the contra angle.How are both people affected doing as of today? we have not seen one since, the other is doing fine.Was there any medical treatment necessary? vitamin e ointment was placed, no further treatment needed.When did this happen, do you have a specific date when? (b)(6) 2024.

• 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: 21108022
• Report Number: 3007007357-2024-00034
• Device Sequence Number: 20838929
• Product Code: EFB
• UDI-Device Identifier: 00304040153857
• UDI-Public: (01)00304040153857
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025
• Report Date (Section F): 01/09/2025

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 CONTRA ANGLE
• Device Catalogue Number: 570-2660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/12/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/13/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/13/2025
• 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 Age: 43 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/09/2025