MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-27 for SYSTEM RADIATION THERAPY manufactured by .
[93046314]
I had 15 sessions of radiation. Total of 40 grays. Last session was (b)(6). The next day i experienced an enormous amount of redness and my breast was extremely hot. I also developed a rash over my entire breast which spread up and over to the center of my chest. It was and still is (5 weeks later) extremely itchy. I also developed a smaller and not so itchy rash on both of my hips. My radiation oncologist deigned that the rash was caused by the radiation. I have spoken to several people i know who have had the same experience. Therefore i no longer trust my radiation oncologist. Hopefully will never have to cross his path again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073566 |
| MDR Report Key | 7059514 |
| Date Received | 2017-11-27 |
| Date of Report | 2017-10-26 |
| Date of Event | 2017-09-22 |
| Date Added to Maude | 2017-11-27 |
| 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 | SYSTEM RADIATION THERAPY |
| Generic Name | SYSTEM, RADIATION THERAPY |
| Product Code | IWB |
| Date Received | 2017-11-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-27 |