MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-02-15 for GENTAL POWER LUX CONTRA ANGLE 25LPA 1002.1526 manufactured by Kavo America.
[20623161]
The head of handpiece became hot and burned the pt. The initial burn created a small blister. Ointment was applied to the burn. She healed fine.
Patient Sequence No: 1, Text Type: D, B5
[20820353]
The doctor was informed that the handpiece bearings are worn and gritty. A service check was recommended to evaluate if it was time for maintenance repair. In addition, maintenance info was reviewed with the dr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419798-2007-00003 |
| MDR Report Key | 818741 |
| Report Source | 05 |
| Date Received | 2007-02-15 |
| Date of Report | 2007-01-11 |
| Date of Event | 2006-11-15 |
| Date Mfgr Received | 2007-01-15 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2007-02-21 |
| 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 | 340 E ROUTE 22 |
| Manufacturer City | LAKE ZURICH IL 60047 |
| Manufacturer Country | US |
| Manufacturer Postal | 60047 |
| 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 | GENTAL POWER LUX CONTRA ANGLE |
| Generic Name | * |
| Product Code | EKK |
| Date Received | 2007-02-15 |
| Returned To Mfg | 2007-01-15 |
| Model Number | 25LPA |
| Catalog Number | 1002.1526 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 806225 |
| Manufacturer | KAVO AMERICA |
| Manufacturer Address | 340 E ROUTE 22 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. Required No Informationntervention | 2007-02-15 |