MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-11 for BRACHYTHERAPY manufactured by Unk.
[108303858]
I was given radiation for prostate cancer and the radiation damaged my rectum at the (b)(6), and now i'm being treated with something called hyperbaric oxygen treatment. I would like to know what can i do about being given too much radiation by this hospital and drs, and did they report this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077203 |
| MDR Report Key | 7510898 |
| Date Received | 2018-05-11 |
| Date of Report | 2018-05-09 |
| Date of Event | 2017-11-28 |
| Date Added to Maude | 2018-05-14 |
| 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 | BRACHYTHERAPY |
| Generic Name | BRACHYTHERAPY |
| Product Code | KXK |
| Date Received | 2018-05-11 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 2018-05-11 |