MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-09-27 for ELECTROTORQUE PLUS 25LPA 1002.1526 manufactured by Kavo Dental.
[21958260]
A dentist reported that a patient received a burn to the side of her tongue and floor of her mouth during the use of a 25lpa handpiece. The patient was prescribed dexamethasone rinse and ibuprofen. It was reported that the patient has since recovered.
Patient Sequence No: 1, Text Type: D, B5
[22114864]
Two hand pieces were received from the dental office; it was reported by the dental office that it is uncertain which handpiece was associated with the incident. Visual inspection of serial number revealed that the bearings are worn and gritty in the drive assembly, shaft and axle. The teeth on the spur wheel are broken and missing. A high level of debris was observed inside the handpiece. Visual inspection of serial number revealed that the bearings are worn and gritty in the drive assembly and shaft. The water port was observed to be clogged. A high level of debris was also observed inside the handpiece. 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 patient. 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 | 1419798-2006-00003 |
| MDR Report Key | 766031 |
| Report Source | 05,07 |
| Date Received | 2006-09-27 |
| Date of Report | 2006-08-29 |
| Date of Event | 2006-07-06 |
| Date Mfgr Received | 2006-08-28 |
| Date Added to Maude | 2006-10-03 |
| 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 | 2006-09-27 |
| Returned To Mfg | 2006-09-05 |
| 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 | 753891 |
| Manufacturer | KAVO DENTAL |
| Manufacturer Address | 340 E. MAIN ST. LAKE ZURICH IL 60047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-09-27 |