MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-09 for KODAK ULTRA-SPEED * manufactured by *.
[16397738]
Denatl x-ray film is defective. Kodak ultraspeed df-58 size 2, made in france. The image develops a moth eaten appearance shortly after developed. Before rptr knew it was the film rptr was changing the solutions, reinstructing the assistants. Because of the problem, rptr had to retake several x-rays. Rptr is upset kodak did not send a recall notice to supplier.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037136 |
| MDR Report Key | 746931 |
| Date Received | 2005-11-09 |
| Date of Report | 2005-10-31 |
| Date of Event | 2005-10-24 |
| Date Added to Maude | 2006-08-15 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KODAK ULTRA-SPEED |
| Generic Name | DENTAL X-RAY FILM |
| Product Code | IWZ |
| Date Received | 2005-11-09 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Expiration Date | 2007-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 734722 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-11-09 |