MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-04-12 for GENTLEPOWER LUX CONTRA ANGLE 25LPA 1.002.1526 manufactured by Kavo America.
[558293]
The handpiece became hot and burned the patient lip. Ointment was applied to the burn.
Patient Sequence No: 1, Text Type: D, B5
[7818206]
Head is damaged due to dent at back end cap. Bearing and gears are worn. Gritty in drive assembly. Shaft and axle have heavy debris. Maintenance information was reviewed with the office and maintenance sheets were sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419798-2007-00015 |
| MDR Report Key | 839563 |
| Report Source | 05 |
| Date Received | 2007-04-12 |
| Date of Report | 2007-04-11 |
| Date of Event | 2007-03-26 |
| Date Mfgr Received | 2007-03-27 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2007-04-23 |
| 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 | 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 | GENTLEPOWER LUX CONTRA ANGLE 25LPA |
| Generic Name | OPERATIVE DENTAL UNIT ACCESSORY |
| Product Code | EKK |
| Date Received | 2007-04-12 |
| Returned To Mfg | 2007-03-28 |
| Model Number | 25LPA |
| Catalog Number | 1.002.1526 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 826851 |
| Manufacturer | KAVO AMERICA |
| Manufacturer Address | 340 E ROUTE 22 LAKE ZURICH IL 60047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-12 |