MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-22 for DF 57C DENTAL X-RAY FILM * manufactured by Eastman Kodak.
[312800]
Kodak df57c dental intraoral x-ray film has some films enclosed in a defective light proof cover. They have a small slit in the side of the cover which allows light entrance, resulting in blacking out of part of the image.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1033299 |
| MDR Report Key | 558326 |
| Date Received | 2004-09-22 |
| Date of Report | 2004-09-22 |
| Date of Event | 2004-09-21 |
| Date Added to Maude | 2004-12-09 |
| 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 | 3 |
| 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 | DF 57C DENTAL X-RAY FILM |
| Generic Name | DENTAL X-RAY FILM |
| Product Code | IWZ |
| Date Received | 2004-09-22 |
| Model Number | DF 57C DENTAL X-RAY |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 547994 |
| Manufacturer | EASTMAN KODAK |
| Manufacturer Address | * ROCHESTER NY * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-09-22 |