MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-03-17 for DEN-TAL-EZ AS2000 ASSISTANT CART AS 2000 * manufactured by Den-tal-ez, Inc..
[20138007]
The hinged top of the as2000 dental assistant cart does not lock in the upright position once the top has been opened. The top is held in the upright position by a metal strap; balancing itself with a slight incline towards the back of the cart. The slightest movement of the cart, which is on wheels, causes the top to crash down. The top is very heavy and must be opened frequently to replace a disposable amalgam trap. An employee has been injured by the cart.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1018433 |
| MDR Report Key | 270006 |
| Date Received | 2000-03-17 |
| Date of Report | 2000-03-10 |
| Date Added to Maude | 2000-03-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEN-TAL-EZ AS2000 ASSISTANT CART |
| Generic Name | ASSISTANT CART |
| Product Code | LDQ |
| Date Received | 2000-03-17 |
| Model Number | AS 2000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 6520L823310511 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 261401 |
| Manufacturer | DEN-TAL-EZ, INC. |
| Manufacturer Address | 101 LINDENWOOD DR, STE 225 VALLEY BROOKE CORPIRATE CTR MALVERN PA 19355 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-03-17 |