MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-06-24 for ELECTROTORQUE PLUS 25LPA 1002.1526 manufactured by Kavo Dental.
[20158771]
A dentist reported that a patient received a second degree burn on the inside of their right cheek during the use of a 25lpa handpiece. It was reported that the pt went to a treatment center later that evening where they were prescribed amoxicillin; 250 mg, po, codeine; 300 mg, po and an unknown ointment. Follow up with the pt in 2005 by the dentist revealed that the pt has recovered, with no further consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419798-2005-00001 |
| MDR Report Key | 617448 |
| Report Source | 05,07 |
| Date Received | 2005-06-24 |
| Date of Report | 2005-04-13 |
| Date of Event | 2005-04-12 |
| Date Mfgr Received | 2005-04-13 |
| Device Manufacturer Date | 2004-08-01 |
| Date Added to Maude | 2005-06-29 |
| 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, DIRECTOR |
| Manufacturer Street | 901 WEST OAKTON ST |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 8476404924 |
| 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 | 2005-06-24 |
| Returned To Mfg | 2005-04-14 |
| 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 | 607136 |
| 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 | 2005-06-24 |