MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-25 for SILHOUETTE CMU-D 2650F manufactured by Dentalez Group.
[1484865]
The product in question has an ongoing history from the first year of purchase/use -2007 & 2007- to present. The dental equipment is mfg by dentalez group located in (b) (4). The equipment is corroding, rusting, peeling and breaking apart after just three years of moderate clinical use. My concern is that it is not known whether these materials are safe to my pts, staff or myself since i am not familiar with the reaction of this equipment to normal clinical use as it follows a pattern of unusual wear and tear in such a short period time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015312 |
| MDR Report Key | 1647151 |
| Date Received | 2010-03-25 |
| Date of Report | 2010-03-25 |
| Date Added to Maude | 2010-04-05 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILHOUETTE |
| Generic Name | DENTALEZ DENTAL CHAIR |
| Product Code | NRU |
| Date Received | 2010-03-25 |
| Model Number | CMU-D 2650F |
| Lot Number | AE 1565 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTALEZ GROUP |
| Manufacturer Address | 2950 HIGHWAY 31 SOUTH BAY MINETTE AL 36507 US 36507 |
| Brand Name | SILHOUETTE |
| Generic Name | DELIVERY UNIT |
| Product Code | NRU |
| Date Received | 2010-03-25 |
| Model Number | CMU. 2431F |
| Lot Number | AE 1653 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | DENTALEZ GROUP |
| Manufacturer Address | 2950 HIGHWAY 31 SOUTH BAY MINETTE AL 36507 US 36507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-03-25 |