MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-28 for ORTHOGAP manufactured by Orthogap, Inc..
[14790]
No msds report available. Is not using fd & c approved pigments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005277 |
| MDR Report Key | 20033 |
| Date Received | 1995-02-28 |
| Date Added to Maude | 1995-03-01 |
| 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 | ORTHOGAP |
| Generic Name | ORTHODONTIC MARKER |
| Product Code | EMP |
| Date Received | 1995-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19927 |
| Manufacturer | ORTHOGAP, INC. |
| Manufacturer Address | TAMPA FL 336133913 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-02-28 |