MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-09-06 for DENTAL WATER SYSTEM manufactured by American Dental Accessories, Inc..
[15712551]
This dental water supply system is supposed to be reprocessed by a procedure that involves an undesignated disinfectant. There are no disinfectants fda cleared for this purpose. The reprocessing procedure has not been cleared by the fda & there is no evidence that it works. The product is not being marketed legally in the usa. There is no evidence that it improves the quality of water delivered by dental instruments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006855 |
| MDR Report Key | 25248 |
| Date Received | 1995-09-06 |
| Date of Report | 1995-08-23 |
| Date Added to Maude | 1995-09-07 |
| 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 | DENTAL WATER SYSTEM |
| Generic Name | WATER SYSTEM |
| Product Code | EIB |
| Date Received | 1995-09-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 25726 |
| Manufacturer | AMERICAN DENTAL ACCESSORIES, INC. |
| Manufacturer Address | 7310 OXFORD ST. MINNEAPOLIS MN 55426 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-09-06 |