MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-05-21 for DOCTOR'S NIGHTGUARD manufactured by Dental Concepts, Inc..
[17426209]
The complainant reported that the product needs a safety seal packaging. They continued that you could tell with other products on the shelf that they had been opened and handled. (www. Dentalconcepts. Com).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003317 |
| MDR Report Key | 411776 |
| Date Received | 2002-05-21 |
| Date Added to Maude | 2002-08-22 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | DOCTOR'S NIGHTGUARD |
| Generic Name | NIGHTGUARD |
| Product Code | BRW |
| Date Received | 2002-05-21 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 400790 |
| Manufacturer | DENTAL CONCEPTS, INC. |
| Manufacturer Address | 650 FROM RD PARAMUS NJ 07652 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-05-21 |