MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-03-20 for ISOVUE 300 (100ML BOTTLE) manufactured by .
[15187554]
At 0850 received isovue iv over 1 minute, 0851 1st scan completed, 0852 patient reported she did not feel right. At 0853 denied shortness of breath or chest pain or tightening. Complained of nausea. Cool wash cloth obtained. Pt became restless and wanted to sit up. Second tech arrived. Pt fell over. O2 started and emergency help obtained (dr + nurse). At 0854 transferred to ed with anaphylactic reaction treated with epinephrine iv, benadryl iv and cimetidine iv and dopamine drip, stabilized and transferred to covenant medical center. Event abated after use stopped or dose reduced? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 938061 |
| MDR Report Key | 938061 |
| Report Source | 99 |
| Date Received | 2007-03-20 |
| Date of Report | 2007-03-19 |
| Date of Event | 2007-03-01 |
| Date Added to Maude | 2007-11-13 |
| 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 | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISOVUE 300 (100ML BOTTLE) |
| Generic Name | 100ML IV |
| Product Code | KTA |
| Date Received | 2007-03-20 |
| Lot Number | 6J08311 |
| ID Number | 00270-1315-35 |
| Device Expiration Date | 2009-10-01 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 912074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 100 | 1. Death | 2007-03-20 |