MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-10-06 for ELECTROTORQUE PLUS 25LPA 1002.1526 manufactured by Kavo Dental.
[16166372]
A dentist reported that a pt received a burn to his tongue during the use of a 25lpa handpiece. The pt was prescribed an antibiotic and tylenol. It was reported that the pt has since recovered.
Patient Sequence No: 1, Text Type: D, B5
[16200606]
The actual unit associated with the incident was returned to the mfr for analysis. Visual inspection of the unit revealed that the head was dented at the back cap and in several places around the water spray plate. The bearings were noted to grind and heat up upon operation of the unit. The unit was disassembled for further analysis and light residue inside the unit was observed. A cautionary statement is included with each unit, which states that electric micromotors generate significantly more power than traditional air turbines and air motors. Due to increased torque and speed, poorly maintained, damaged or misused handpieces can potentially generate frictional heat capable of causing serious burn injuries to the pt. It also states that the head of the attachment should not be used as a cheek or tongue retractor.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419798-2006-00004 |
| MDR Report Key | 768383 |
| Report Source | 05,07 |
| Date Received | 2006-10-06 |
| Date of Report | 2006-09-08 |
| Date of Event | 2006-08-31 |
| Date Mfgr Received | 2006-09-08 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2006-10-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN MILLER, DIR |
| Manufacturer Street | 901 WEST OAKTON STREET |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 8473643931 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTROTORQUE PLUS |
| Generic Name | ELECTRIC DENTAL HANDPIECE |
| Product Code | EKK |
| Date Received | 2006-10-06 |
| Returned To Mfg | 2006-09-14 |
| Model Number | 25LPA |
| Catalog Number | 1002.1526 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 756255 |
| Manufacturer | KAVO DENTAL |
| Manufacturer Address | 340 EAST MAIN ST. LAKE ZURICH IL 60047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-10-06 |