MAUDE Adverse Event Report: RADIATION 200GY TOTAL 6000GY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Exsanguination (1841); Ulceration (2116); Loss of consciousness (2418); Respiratory Failure (2484); Loss Of Pulse (2562)

Event Date 12/02/2018

Event Type  Death  

Event Description

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.

Event Description

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.

• Brand Name: RADIATION 200GY TOTAL 6000GY
• Type of Device: RADIATION 200GY TOTAL 6000GY
• MDR Report Key: 8202264
• MDR Text Key: 131653572
• Report Number: 8202264
• Device Sequence Number: 1
• Product Code: MUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Weight: 70