MAUDE Adverse Event Report: KLS MARTIN LP BEN AIRE DRILL; DRILL, DENTAL, INTRAORAL

Model Number 1600436

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 04/18/2014

Event Type  malfunction  

Event Description

Bur was seated and locked.The whole handpiece heated and burned patient's lip.
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manufacturer response for ben aire hand piece, ben aire drill (per site reporter).
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the handpiece has been sent to the manufacturer for inspection and repair.

• Brand Name: BEN AIRE DRILL
• Type of Device: DRILL, DENTAL, INTRAORAL
• Manufacturer (Section D): KLS MARTIN LP; 11239-1 st. john¿s pkwy 5; jacksonville FL 32246
• MDR Report Key: 3820042
• MDR Text Key: 4502659
• Report Number: 3820042
• Device Sequence Number: 1
• Product Code: DZA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 1600436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2014
• Date Report to Manufacturer: 05/20/2014
• Patient Sequence Number: 1
• Patient Age: 18 YR