MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-13 for RADIATION manufactured by .
[5294324]
Peg tube placement for grade 3 oral pain unlikely related to the agent. Event took place during cycle 6. Suspect product: radiation. Dose frequency & route used: 6000 cgy. Therapy dates: (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039151 |
| MDR Report Key | 4270324 |
| Date Received | 2014-11-13 |
| Date of Report | 2014-11-06 |
| Date of Event | 2014-09-29 |
| Date Added to Maude | 2014-11-24 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIATION |
| Generic Name | RADIATION |
| Product Code | KPQ |
| Date Received | 2014-11-13 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-11-13 |