MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-01-11 for GENTLEPOWER LUX CONTRA ANGLE 25LPA 1002.1526 manufactured by Kaltenbach & Voigt Gmbh.
[745892]
Head of handpiece overheated and caused burn to pt's lip. Pt was prescribed ointment.
Patient Sequence No: 1, Text Type: D, B5
[7949899]
Bearings were worn and gritty in drive assembly and shaft. Head damaged, medium debris level. Office was informed about the debris level in handpiece and dented head. Proper maintenance to handpiece was discussed. Maintenance information was reviewed with the office. Office was informed to run handpiece through a second cleaning cycle if black or dark grey spray was seen after cleaning.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010493-2008-00001 |
| MDR Report Key | 977546 |
| Report Source | 05 |
| Date Received | 2008-01-11 |
| Date of Report | 2007-01-10 |
| Date of Event | 2007-12-11 |
| Date Mfgr Received | 2008-01-10 |
| Device Manufacturer Date | 2004-09-27 |
| Date Added to Maude | 2008-01-15 |
| 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 | 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 | 2008-01-11 |
| Returned To Mfg | 2007-01-08 |
| 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 | 946365 |
| Manufacturer | KALTENBACH & VOIGT GMBH |
| Manufacturer Address | BISMARCKRING 39 BIBERACH GM D-88400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-01-11 |