MAUDE Adverse Event Report: IMRT; RADIATION THERAPY

Device Problem Insufficient Information (3190)

Patient Problems Dysphagia/ Odynophagia (1815); Feeding Problem (1850); Gastritis (1874); Pain (1994)

Event Date 04/17/2015

Event Type  Injury  

Event Description

Patient with history of non-small cell lung cancer being treated with daily radiation, weekly abraxane and carboplatin developed increasing epigastric pain and poor po intake.On (b)(6) 2015 she complained of severe epigastric pain and progressive odynophagia and anorexia.She was admitted to (b)(6) on (b)(6) 2015 for probably grade 3 esophagitis and grade 3 gastritis.Dose, frequency and route used: imrt 60 gy / 30 fx.Therapy dates: (b)(6) 2015.

• Brand Name: IMRT
• Type of Device: RADIATION THERAPY
• MDR Report Key: 4737370
• MDR Text Key: 5768242
• Report Number: MW5042339
• 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: Nurse
• 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: 04/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: ABRAXANE 40MG/M2 WEEKLY; CARBOPLATIN ADC=2X1 DOSE WEEKLY
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Weight: 62