MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for ISOVUE 370 CONTRAST DYE manufactured by Bracco Injeneering S.a..
[121988311]
Reported states that after she had a ct scan, she began to experience burning pain that began in her eyes then radiated throughout her entire body that persists to this day. She also experiences chest pain/tightness and respiratory difficulties as well. She believes that this is the result of the isovue used in the ct scan. She says her doctor has been of no help.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080122 |
| MDR Report Key | 7910416 |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-08-01 |
| Date Added to Maude | 2018-09-26 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ISOVUE 370 CONTRAST DYE |
| Generic Name | MEDIUM CONTRAST, RADIOLOGIC |
| Product Code | KTA |
| Date Received | 2018-09-25 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRACCO INJENEERING S.A. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-25 |