MAUDE Adverse Event Report: RADIATION

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Unspecified Infection (1930); Infiltration into Tissue (1931); Test Result (2695)

Event Date 07/12/2014

Event Type  Injury  

Event Description

Protocol mc13c2 cycle 8 - infection lung: grade 3 attribution 2.White blood cell decrease: grade 2 attribution 2.Pt presented to hospital with fever and dry, raspy cough.Chest x-ray revealed a left lower lobe infiltrate.Blood cultures were obtained and remained negative during hospital stay.He was placed on broad-spectrum antibiotics which were subsequently switched to levaquin for a total of 7 days.He improved during his hospital stay and did not require oxygen.He was discharged on (b)(6) 2014.Radiation dose 6000 cgy, (b)(6) 2014.

• Brand Name: RADIATION
• Type of Device: RADIATION
• MDR Report Key: 4305491
• MDR Text Key: 5191132
• Report Number: MW5039395
• 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: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2014
• Patient Sequence Number: 1
• Treatment: RADIATION,; 25 ML 5 X DAILY PO - (B)(6) 2014; 10% N-ACETYLCYSTEINE IN RINCINOL SOLUTION,
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 79