MAUDE Adverse Event Report: W&H FORZA PRO 1:5 FG OPTIC; HAND PIECE

Catalog Number 5029811U0

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 03/19/2024

Event Type  Injury  

Event Description

Reporting out of an abundance of caution.The forza pro electric high speed got very hot while using it with a bur for routine fillings on the right side of mouth.The head of the handpiece touched the patient's tongue and put a noticeable burn on the right later border of the tongue.The dentist noticed it, but the patient was numb and did not feel it.No follow-up treatment was reported.

Event Description

Reporting out of an abundance of caution.The forza pro electric high speed got very hot while using it with a bur for routine fillings on the right side of mouth.The head of the handpiece touched the patient's tongue and put a noticeable burn on the right later border of the tongue.The dentist noticed it, but the patient was numb and did not feel it.No follow-up treatment was reported.The patient was told it should heal in 10-14 days.If there are any issues he should call the office.

• Brand Name: FORZA PRO 1:5 FG OPTIC
• Type of Device: HAND PIECE
• Manufacturer (Section D): W&H; ignaz-glaser-strasse 53, 5111; bürmoos, ; AU
• MDR Report Key: 19130387
• MDR Text Key: 340446674
• Report Number: 1032227-2024-00002
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/27/2024,04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5029811U0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2024
• Distributor Facility Aware Date: 03/19/2024
• Event Location: Other
• Date Report to Manufacturer: 04/27/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White