MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-12-28 for GENTLEPOWER LUX CONTRA ANGLE 25LPA 1002.1526 manufactured by Kaltenbach & Voigt Gmbh.
[753617]
Head of handpiece overheated and burned patient on the lr premolar check. Patient was prescribed lortab 7. 5 mg pain medication.
Patient Sequence No: 1, Text Type: D, B5
[8094750]
Maintenance information was reviewed with the office. Bearings were worn and gritty in drive assembly, shaft, and axle. Bearings falling apart. Head damaged. Covernut damaged. High debris level. Damage was due to not following maintenance instructions properly. Complainant was informed that head of handpiece was dented and that in the future to send in all dented handpieces to kavo for evaluation and repair.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010493-2007-00001 |
| MDR Report Key | 970588 |
| Report Source | 05 |
| Date Received | 2007-12-28 |
| Date of Report | 2007-12-05 |
| Date of Event | 2007-12-03 |
| Date Mfgr Received | 2007-12-05 |
| Date Added to Maude | 2008-01-03 |
| 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, MGR |
| Manufacturer Street | 901 WEST OAKTON ST. |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 8473643958 |
| Manufacturer G1 | KALTENBACH & VOIGT GMBH |
| Manufacturer Street | BISMARCKRING 39 |
| Manufacturer City | BIBERACH D-88400 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-88400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| 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 | 2007-12-28 |
| Returned To Mfg | 2007-12-11 |
| Model Number | 25LPA |
| Catalog Number | 1002.1526 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 940958 |
| Manufacturer | KALTENBACH & VOIGT GMBH |
| Manufacturer Address | BISMARCKRING 39 BIBERACH GM D-88400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-12-28 |