MAUDE Adverse Event Report:; SBET RADIATION

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Infiltration into Tissue (1931); Pain (1994); Dizziness (2194); Respiratory Tract Infection (2420); Test Result (2695); No Code Available (3191)

Event Date 12/21/2014

Event Type  Injury  

Event Description

Patient was registered to bruog259 study on (b)(6) 2014.Therapy started on (b)(6) 2014 and second treatment was on (b)(6) 2014.Received 1400 cgy on both dates for total done 2800 cgy.On (b)(6) 2014 patient presented to treating hospital emergency department with upper respiratory symptoms consisting of dry cough, runny nose.Chest x-ray was done which showed right lower lobe infiltrate.The patient was started on iv antibiotics and discharged on (b)(6) 2014 on oral antibiotics.Patient also complained of bilateral thigh pain - grade 2 suspected to be related to chemotherapy, dizziness grade 1 - resolved on (b)(6) 2014 and considered related to viral process thrombocytopenia grade 1, grade 2 at discharge - possibly related to chemotherapy.Hyponatremia grade 3, grade 1 at discharge - possibly related to chemotherapy, upper respiratory infection grade 3, grade 2 at discharge - possibly related to chemo.Nsclc left lung.

• Type of Device: SBET RADIATION
• MDR Report Key: 4437979
• MDR Text Key: 5310192
• Report Number: MW5040235
• 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: 01/12/2015

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: 01/13/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR