MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-02-22 for GENTLEPOWER LUX CONTRA ANGLE 25LPA 1002.1526 manufactured by Kaltenbach & Voigt Gmbh.
[15605152]
Backup of the handpiece overheated and caused a small burn to pt's lower lip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419798-2008-00004 |
| MDR Report Key | 1003373 |
| Date Received | 2008-02-22 |
| Date of Report | 2008-02-05 |
| Date Facility Aware | 2008-02-05 |
| Report Date | 2008-02-22 |
| Date Reported to FDA | 2008-02-22 |
| Date Reported to Mfgr | 2008-02-05 |
| Date Added to Maude | 2008-02-28 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENTLEPOWER LUX CONTRA ANGLE 25LPA |
| Generic Name | DENTAL HANDPIECES AND ACCESSORIES |
| Product Code | EKK |
| Date Received | 2008-02-22 |
| Returned To Mfg | 2008-02-11 |
| Model Number | 25LPA |
| Catalog Number | 1002.1526 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 971471 |
| Manufacturer | KALTENBACH & VOIGT GMBH |
| Manufacturer Address | BLAMERCKRING 39 BIBERACH GM D-00400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-02-22 |