MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-26 for RADIATION 200GY TOTAL 6000GY manufactured by .
[131653572]
Pt began to have a nose bleed. As per family pt was instructed to go to er if developed a nose bleed. Pt started to bleed profusely and family called 911. By the time ems arrived at the scene, pt was lying in a pool of blood and was unresponsive without pulse and respiration. Cpr started, ems were not able to resuscitate the pt. According to treating md from an office visit on (b)(6) 2018, pt had a non healing ulceration involving the left soft palate involving the superior portion of the tonsillar fossa and the soft palate on the left side. This consistent with left-side ulceration most likely related to radiation. There is a fungal debris present. On office visit from (b)(6) 2018, auscultation of the left carotid demonstrated a bruit. Examination revealed an ulceration extending from upper portion of the left tonsilar pillar to his lateral pharyngeal wall inferiorly over a distance of approx 2-3 centimeters. Palpitation revealed no evidence of pulsation in the depths of the ulcer. This carotid rupture if a rare, but known side effect of rt, and this event, do not believe it is related to all with the study drug. This event is reported as being unexpected as it is not in the ib.
Patient Sequence No: 1, Text Type: D, B5
[131728316]
This carotid rupture is a rare but know side effect of radiation, and this event is not believed to be related at all to the study drug. This event is being reported as unexpected as it is not in the informed consent. Our regulatory dept is working on amendment to add this to our informed consent as a rare risk but possible of the radiation treatment. Ind# (b)(4). Diagnosed for use: head and neck cancer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8202264 |
| MDR Report Key | 8202264 |
| Date Received | 2018-12-26 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-12-02 |
| Date Added to Maude | 2018-12-28 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIATION 200GY TOTAL 6000GY |
| Generic Name | RADIATION 200GY TOTAL 6000GY |
| Product Code | MUJ |
| Date Received | 2018-12-26 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-12-26 |