MAUDE Adverse Event Report:; RADIATION

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Unspecified Infection (1930); Pneumonia (2011); Weakness (2145)

Event Date 01/08/2015

Event Type  Injury  

Event Description

Mc1273 cycle 3.Thromboembolic event grade: 3 attribution: 3.Lung infection: grade: 3 attribution: 4.Patient presented to local hospital with increased shortness of breath and weakness.Patient had a ct chest which showed bilateral pulmonary emboli.He was admitted for acute pulmonary embolism/pneumonia.Patient was started on clindamycin, vancomycin and zosyn.He was also placed on lovenox.Patient improved and was sent home (b)(6) 2015 on lovenox bridging and coumadin, and antibiotics to complete the course for this pneumonia.Therapy dates: (b)(6) 2012 - (b)(6) 2014.Indication: ca of right oropharynx.

• Type of Device: RADIATION
• MDR Report Key: 4450765
• MDR Text Key: 5392545
• Report Number: MW5040358
• 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: 01/16/2015

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: 01/16/2015
• Patient Sequence Number: 1
• Treatment: DOCETAXEL 31 MG D1, D8 IV; DOCETAXEL 31 MG D1, D8 IV
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 83