MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-09-21 for GENTLEPOWER LUX CONTRA ANGLE 25LPA 1002.1526 manufactured by Kavo America.
[19494761]
The handpiece overheated and burned the inside cheek by the corner of the mouth. A few days later, the burn became worse and the patient was referred to an oral surgeon.
Patient Sequence No: 1, Text Type: D, B5
[19640259]
Maintenance info was reviewed with the office and maintenance sheets were sent. Instructions for use were reviewed with the office. Bearings were worn and gritty in drive assembly and shaft. Debris level was medium.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419798-2007-00022 |
| MDR Report Key | 916794 |
| Report Source | 05 |
| Date Received | 2007-09-21 |
| Date of Report | 2007-08-17 |
| Date of Event | 2007-04-27 |
| Date Mfgr Received | 2007-08-17 |
| Device Manufacturer Date | 2006-07-27 |
| Date Added to Maude | 2007-10-01 |
| 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 EAST MAIN ST. |
| 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 | 2007-09-21 |
| Returned To Mfg | 2007-08-20 |
| 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 | 892723 |
| Manufacturer | KAVO AMERICA |
| Manufacturer Address | 340 EAST MAIN ST. LAKE ZURICH IL 60047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-09-21 |