MAUDE Adverse Event Report: RADIATION MACHINE

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Necrosis (1971); Disability (2371)

Event Date 07/15/2012

Event Type  Injury  

Event Description

I received radiation for colo/rectal cancer at (b)(6) hospital, (b)(6) in (b)(6) 2012.The tumor was very low in the rectal area, but the radiation caused cell death of all of my colon except an inch or two and also caused cell death of the small intestine - i lost approximately 1/3rd.I was put in hospice after failed surgery to correct the damage from radiation enteritis - with 3 days to live.Have had multiple surgeries, lifelong medical problems, disability etc.No one ever admitted that there was a problem, which means people are still being hurt and someone should do something.When the doctors told me i was going to die they said, "we've been having a lot of problems with this lately." killing people with radiation.

• Brand Name: RADIATION MACHINE
• Type of Device: RADIATION
• MDR Report Key: 4729853
• MDR Text Key: 5668305
• Report Number: MW5042283
• Device Sequence Number: 1
• Product Code: IYE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 32 YR
• Patient Weight: 59