MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-08-20 for OPTIRAY (IOVERSOL) 350 manufactured by .
[911255]
Pt given iv contrast in preparation for ct scan. Pt experienced allergic reaction including swelling, nausea, hypotension and breathing difficulty. Dose, frequency & route used: 125ml; 1 dose, intravenous. Diagnosis for use: ct scan, radiopaque agent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1131168 |
| MDR Report Key | 1131168 |
| Report Source | 99 |
| Date Received | 2008-08-19 |
| Date of Report | 2008-08-18 |
| Date of Event | 2008-08-06 |
| Date Facility Aware | 2008-08-06 |
| Report Date | 2008-08-18 |
| Date Reported to FDA | 2008-08-18 |
| Date Reported to Mfgr | 2008-08-18 |
| Date Added to Maude | 2008-08-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIRAY (IOVERSOL) 350 |
| Generic Name | NONE |
| Product Code | KTA |
| Date Received | 2008-08-20 |
| Lot Number | P186B |
| Device Expiration Date | 2010-04-01 |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1136419 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2008-08-19 |