MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-16 for DENTAL SYRINGE FILTER DEVICE manufactured by Dci Intl. Co..
[14937]
This syringe is promoted with misleading language that claims that this device removes "contaminants", giving the incorrect impression that it makes a real contribution to infection control, which it certainly does not. This medical device is clearly being presented in a misleading and dangerous way designed to give the user a false sense of security about what he is filtering out. It is posturing as an infection control device but serves no useful purpose as such. (*)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005464 |
| MDR Report Key | 20327 |
| Date Received | 1995-03-16 |
| Date of Report | 1995-02-22 |
| Date Added to Maude | 1995-03-17 |
| 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 SYRINGE FILTER DEVICE |
| Generic Name | DENTAL AIR/WATER SYRINGE |
| Product Code | EIB |
| Date Received | 1995-03-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 20214 |
| Manufacturer | DCI INTL. CO. |
| Manufacturer Address | NEWBERG OR 97132 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-03-16 |