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 manufactured by Eastman Kodak Company.
[16839409]
A chest x-ray showed an osteoblastic malignant tumor on an elderly pt. Additional radiographs of the shoulder and humerus did not show the tumor.
Patient Sequence No: 1, Text Type: D, B5
[17053477]
The cassette has been removed from use and will be evaluated by kodak once received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317307-2006-00008 |
| MDR Report Key | 736524 |
| Report Source | 05,06 |
| Date Received | 2006-07-01 |
| Date of Report | 2006-06-29 |
| Date of Event | 2006-04-05 |
| Date Mfgr Received | 2006-06-08 |
| 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 | OT |
| 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 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 724413 |
| Manufacturer | EASTMAN KODAK COMPANY |
| Manufacturer Address | 343 STATE STREET ROCHESTER NY 14650 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-07-01 |