MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-13 for RADIOACTIVE IODINE (131) * manufactured by *.
[17726671]
Patient with thyrotoxic hypokalemic periodic paralysis (thpp) who also experienced a paralysis attack ten days after the administration of radioiodine despite the treatment with propranolol. The patient was admitted to a medical center 10 days after radioactive iodine treatment for several-hour episode of paralysis with areflexia in all four limbs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035735 |
| MDR Report Key | 758233 |
| Date Received | 2005-06-13 |
| Date of Report | 2005-05-20 |
| Date Added to Maude | 2006-09-11 |
| 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 |
| 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 | RADIOACTIVE IODINE (131) |
| Generic Name | 10 MCI |
| Product Code | KTA |
| Date Received | 2005-06-13 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 746137 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2005-06-13 |