MAUDE Adverse Event Report: RADIATION

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 09/16/2014

Event Type  Injury  

Event Description

Peg tube placement for grade 3 oral pain unlikely related to the agent.Event took place during cycle 4.Dose: 7000 cgy, (b)(6) 2014.

• Brand Name: RADIATION
• Type of Device: RADIATION
• MDR Report Key: 4253509
• MDR Text Key: 4992363
• Report Number: MW5039035
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2014
• Patient Sequence Number: 1
• Treatment: N-ACETYLCYSTEINE 5 ML (B)(6) 2014
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 99