MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-15 for SOURCE, BRACHYTHERAPY, RADIONUCLIDE manufactured by Unk.
[145478731]
Reporter stated he had brachytherapy in 2016 as part of his cancer treatment and he is suffering from the adverse effects ever since. Reporter stated the radiation therapy should not have been done to him in the first place since he has a paralyzed diaphragm. He also said even though the (b)(6) recommended the treatment to be done in 10 days they did it in 5 days. He said he was fine for the first few days after the treatment. By the third or fourth day, he started having flu like symptoms, muscle pain, joint pain and difficulty breathing. To this day he takes prednisone 30 mg, and sleeps on oxygen. He cannot walk not more than 15 feet and does not do any work as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086696 |
| MDR Report Key | 8616237 |
| Date Received | 2019-05-15 |
| Date of Report | 2019-05-15 |
| Date of Event | 2016-01-14 |
| Date Added to Maude | 2019-05-16 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SOURCE, BRACHYTHERAPY, RADIONUCLIDE |
| Generic Name | SOURCE, BRACHYTHERAPY, RADIONUCLIDE |
| Product Code | KXK |
| Date Received | 2019-05-15 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-05-15 |