MAUDE Adverse Event Report: SOURCE, BRACHYTHERAPY, RADIONUCLIDE

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

Patient Problems Dyspnea (1816); Pain (1994); Arthralgia (2355); Ambulation Difficulties (2544)

Event Date 01/14/2016

Event Type  Injury  

Event Description

Reporter stated he had brachytherapy in 2016 as part of his cancer treatment and he is suffering from the adverse effects ever since.Reporter stated the radiation therapy should not have been done to him in the first place since he has a paralyzed diaphragm.He also said even though the (b)(6) recommended the treatment to be done in 10 days they did it in 5 days.He said he was fine for the first few days after the treatment.By the third or fourth day, he started having flu like symptoms, muscle pain, joint pain and difficulty breathing.To this day he takes prednisone 30 mg, and sleeps on oxygen.He cannot walk not more than 15 feet and does not do any work as a result.

• Brand Name: SOURCE, BRACHYTHERAPY, RADIONUCLIDE
• Type of Device: SOURCE, BRACHYTHERAPY, RADIONUCLIDE
• MDR Report Key: 8616237
• MDR Text Key: 145478731
• Report Number: MW5086696
• Device Sequence Number: 1
• Product Code: KXK
• 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: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 73 YR
• Patient Weight: 96