MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-02 for OPTIRAY 320 * manufactured by Mallinckrodt.
[620409]
Consumer states that she has had a ct scan before and that this was her second scan taken at facility. One hour after being injected with dye she had a metallic taste in her mouth. She contacted her dr, who told her it would go away in a day, but to date the taste remains. One week after her ct, she had an ultrasound and the taste continued. According to the radiologist, she was told that less than 1% of pts have experienced such a problem. Her concern is that she now requires cat scans every 6 months for next several years and she forsees this problem. Consumer states that over the past 2 months. She had made several calls regarding the side effects of her most recent ct, but no one had called her back to follow up. Fda needs to know and should be the one to call the mfr to call her back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042777 |
| MDR Report Key | 844439 |
| Date Received | 2007-05-02 |
| Date of Report | 2007-05-02 |
| Date of Event | 2007-03-07 |
| Date Added to Maude | 2007-05-07 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIRAY 320 |
| Generic Name | NON IONIC IODINE CONTRAST INJECTABLE |
| Product Code | KTA |
| Date Received | 2007-05-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 831626 |
| Manufacturer | MALLINCKRODT |
| Manufacturer Address | * ST. LOUIS US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-02 |