MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-07-20 for OPTIRAY 300 (100 MLS) manufactured by Mallinckrodt.
[678882]
After an injection of optiray 300, pt complained of itchy throat, lars, warmth and nausea. Pt was treated with benadryl, epinephrine and solumedrol. Pt was brought to the er and admitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 883434 |
| MDR Report Key | 883434 |
| Report Source | 99 |
| Date Received | 2007-07-20 |
| Date of Report | 2007-06-28 |
| Date of Event | 2007-06-21 |
| Date Facility Aware | 2007-06-21 |
| Report Date | 2007-06-28 |
| Date Reported to FDA | 2007-07-17 |
| Date Reported to Mfgr | 2007-07-17 |
| Date Added to Maude | 2007-08-09 |
| 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 | 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 300 (100 MLS) |
| Generic Name | CONTRAST MEDIUM |
| Product Code | KTA |
| Date Received | 2007-07-20 |
| Lot Number | BOX # M091J |
| Operator | HEALTH PROFESSIONAL |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 868265 |
| Manufacturer | MALLINCKRODT |
| Manufacturer Address | 675 MC DONNELL HAZELWOOD MO 63042 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-07-20 |