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.
[558296]
The handpiece became hot and burned the patient lip. The burns were slightly larger than handpiece head. Ointment was applied to the burn.
Patient Sequence No: 1, Text Type: D, B5
[7818208]
Head is damaged due to multiple dents bearings/ gears are worn and gritty in drive assembly and shaft had heavy debris. Maintenance information was reviewed with the doctor and maintenance sheets were sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419798-2007-00014 |
| MDR Report Key | 839572 |
| Report Source | 05 |
| Date Received | 2007-04-12 |
| Date of Report | 2007-04-11 |
| Date of Event | 2007-03-21 |
| Date Mfgr Received | 2007-03-26 |
| Device Manufacturer Date | 2005-08-01 |
| 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 | 826860 |
| 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 |