MAUDE Adverse Event Report: RADIATION; RADIATION, 3600 CGY

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 12/28/2014

Event Type  Injury  

Event Description

Protocol: (b)(4), cycle 2 (14 day post rxt).Lung infection: grade 3 attribution 4.Pt admitted to hosp and treated for pneumonia on (b)(6) 2014.Pneumonia was thought to be secondary to aspiration vs community-acquired.Blood cultures obtained approx no growth after 24 hrs.Video swallow performed on (b)(6) 2014, which was negative for any aspiration.Pt treated with iv levofloxacin and iv flagyl.Pt discharged on (b)(6) 2014.Diagnosis for use: scc of right oropharynx.

• Brand Name: RADIATION
• Type of Device: RADIATION, 3600 CGY
• MDR Report Key: 4397639
• MDR Text Key: 5434239
• Report Number: MW5040022
• 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: 12/30/2014

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: 12/30/2014
• Patient Sequence Number: 1
• Treatment: DOCETAXEL, DOSE: 31MG, FREQUENCY: ONCE WEEKLY,; ROUTE USED: IV (B)(6) 2014
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 84