MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-09-24 for GENTLEPOWER LUX CONTRA ANGLE 25LPA 1002.1526 manufactured by Kavo America.
[16109948]
The handpiece became hot and burned the inside cheek of the patient's mouth. Patient was prescribed "viscus laticane" and "parogard". Patient is getting better.
Patient Sequence No: 1, Text Type: D, B5
[16149922]
Maintenance information was reviewed with the office and maintenance sheets were sent. Bearings were worn and gritty in drive assembly and shaft. Debris level was medium.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419798-2007-00023 |
| MDR Report Key | 916780 |
| Report Source | 99 |
| Date Received | 2007-09-24 |
| Date of Report | 2007-08-22 |
| Date of Event | 2007-08-21 |
| Date Mfgr Received | 2007-08-25 |
| Date Added to Maude | 2007-09-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARI LAMBERT, MANAGER |
| Manufacturer Street | 340 E. MAIN STREET |
| Manufacturer City | LAKE ZURICH IL 60047 |
| Manufacturer Country | US |
| Manufacturer Postal | 60047 |
| Manufacturer Phone | 8473643958 |
| 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 | 2007-09-24 |
| Returned To Mfg | 2007-08-25 |
| Model Number | 25LPA |
| Catalog Number | 1002.1526 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 891406 |
| Manufacturer | KAVO AMERICA |
| Manufacturer Address | 340 E. MAIN STREET LAKE ZURICH IL 60047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-09-24 |