MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-02-22 for GENTLEPOWER LUX CONTRA ANGLE 25LPA 1002.1526 manufactured by Kaltenbach & Voigt Gmbh.
[794953]
Backcap of the handpiece overheated and caused a small burn to patient's lower lip.
Patient Sequence No: 1, Text Type: D, B5
[8091180]
Patient was prescribed 800 mg ibuprofen. Due to improper maintenance, bearings were worn and gritty in drive assembly and shaft. Bearings falling apart. Medium debris level. Proper maintenance to handpiece was discussed. Replacement was sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010493-2008-00004 |
| MDR Report Key | 1001059 |
| Report Source | 05 |
| Date Received | 2008-02-22 |
| Date of Report | 2008-02-05 |
| Date Mfgr Received | 2008-02-05 |
| Device Manufacturer Date | 2007-04-11 |
| Date Added to Maude | 2008-02-26 |
| 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 |
| 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 | 2008-02-22 |
| Returned To Mfg | 2008-02-11 |
| Model Number | 25LPA |
| Catalog Number | 1002.1526 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 970078 |
| Manufacturer | KALTENBACH & VOIGT GMBH |
| Manufacturer Address | BISMARCKRING 39 BIBERACH GM D-88400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-02-22 |