MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-10-15 for DIGITAL FLUOROSCOPY SYSTEM DFP 2000A * manufactured by Toshiba American Medical Systems, Inc..
[117760]
Pt underwent cardiac catheterization 9/13/96. On 10/22/98 referred to dermatology for "rash on back". In 6/97 had another cardiac catheterization. Continued to be seen by dermatology, and in 12/97 the suspicion of chronic radiation dermatitis was raised. It is now felt that this is the likely diagnosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014806 |
| MDR Report Key | 193461 |
| Date Received | 1998-10-15 |
| Date of Report | 1998-10-13 |
| Date of Event | 1996-09-01 |
| Date Added to Maude | 1998-10-28 |
| 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 | DIGITAL FLUOROSCOPY SYSTEM |
| Generic Name | * |
| Product Code | IZG |
| Date Received | 1998-10-15 |
| Model Number | DFP 2000A |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 187982 |
| Manufacturer | TOSHIBA AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 2441 MICHELLE DR. TUSTIN CA 92780 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-10-15 |