MAUDE Adverse Event Report: RADIATION THERAPY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 06/01/2015

Event Type  Injury  

Event Description

After radiation and mastectomy (right side stage 3 breast cancer diagnosed in september 2013) i had osteomyelitis in the sternum.My oncologist thought it was bone metastasis at first but an attempted biopsy revealed a sternum (bone) infection.The infectious disease dr at (b)(6) said that he sees this with pts who have undergone radiation.The tissue / bone is more susceptible to infection.

• Brand Name: RADIATION THERAPY
• Type of Device: RADIATION THERAPY
• MDR Report Key: 7780324
• MDR Text Key: 117131801
• Report Number: MW5079134
• Device Sequence Number: 1
• Product Code: MUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR
• Patient Weight: 68