MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-04-11 for ELECTROTORQUE PLUS 25LPA 1002.1526 manufactured by Kavo Dental.
[441865]
A dentist reported that a patient received a burn on the lower right side of his lip during the use of a 25lpa handpiece. Petroleum jelly was applied to the burn. Additionally, the patient's prescription for amoxicillin (dose unknown) was continued. It was reported that the patient had been previously prescribed this medication for strep throat. Follow up with the patient in 04/06 and 03/06 by the dentist revealed that the patient has recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419798-2006-00001 |
| MDR Report Key | 699799 |
| Report Source | 05,07 |
| Date Received | 2006-04-11 |
| Date of Report | 2006-03-15 |
| Date of Event | 2006-02-15 |
| Date Mfgr Received | 2006-03-15 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2006-04-17 |
| 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 | 2006-04-11 |
| Returned To Mfg | 2006-04-04 |
| 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 | 688889 |
| Manufacturer | KAVO DENTAL |
| Manufacturer Address | 340 EAST MAIN ST. LAKE ZURICH IL 60047 US |
| Baseline Brand Name | ELECTROTORQUE PLUS |
| Baseline Generic Name | ELECTRIC DENTAL HANDPIECE |
| Baseline Model No | 25LPA |
| Baseline Catalog No | 1002.1526 |
| Baseline ID | NA |
| Baseline Device Family | ELECTROTORQUE PLUS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K934783 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-04-11 |