MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-07-01 for KODAK DIRECTVIEW CR CASSETTE 132-4326 manufactured by Eastman Kodak Company.
[472930]
An artifact on a radiograph of the right knee resembled a bone tumor distal femur. When reading the radiograph, the radiologist thought what he observed was an artifact but ran an additional radiograph to clarify and confirm.
Patient Sequence No: 1, Text Type: D, B5
[7848915]
Kodak received the screen and cassette for evaluation. Our evaluation included creating and printing flat field images and a physical examination of the screen. The flat field images were printed at an extreme contrast in order to ehance any image artifacts. The flat field images showed artifacts that was classified as mottle. The physical examination did not show any physical damage to the screen. Artifact investigation conducted by kodak have shown that mottle artifacts is caused when a screen is re-inserted into a cassette not fully dry. The cleaning solution is then absorbed by the protective foam and, in contact with the screen surface, will cause an artifact. The affected cr screen was removed and replaced with a new cr screen.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317307-2006-00010 |
| MDR Report Key | 736514 |
| Report Source | 05,06 |
| Date Received | 2006-07-01 |
| Date of Report | 2006-06-29 |
| Date of Event | 2006-04-24 |
| Date Mfgr Received | 2006-06-08 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2006-07-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN PARDO |
| Manufacturer Street | 343 STATE STREET |
| Manufacturer City | ROCHESTER NY 146501131 |
| Manufacturer Country | US |
| Manufacturer Postal | 146501131 |
| Manufacturer Phone | 5857245974 |
| Manufacturer G1 | EASTMAN KODAK COMPANY |
| Manufacturer Street | 1041 RIDGE ROAD WEST BUILDING 214 |
| Manufacturer City | ROCHESTER NY 14652349 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14652 3491 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KODAK DIRECTVIEW CR CASSETTE |
| Generic Name | CR RIGID CASSETTE |
| Product Code | IXA |
| Date Received | 2006-07-01 |
| Returned To Mfg | 2006-05-23 |
| Model Number | NA |
| Catalog Number | 132-4326 |
| Lot Number | 1799 |
| ID Number | 1799004254CR9842 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 724403 |
| Manufacturer | EASTMAN KODAK COMPANY |
| Manufacturer Address | 343 STATE STREET ROCHESTER NY 14650 US |
| Baseline Brand Name | KODAK DIRECTVIEW CR CASSETTE |
| Baseline Generic Name | CR RIGID CASSETTE |
| Baseline Model No | NA |
| Baseline Catalog No | 132-4326 |
| Baseline ID | 1799004254CR984 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-07-01 |