MAUDE Adverse Event Report: LINEAR ACCELERATOR

Device Problem Radiation Overexposure (3017)

Patient Problems Radiation Burn (1755); Skin Discoloration (2074)

Event Date 10/08/2018

Event Type  Injury  

Event Description

Caller called to report on behalf of her friend (b)(6) who had linear accelerator treatments at (b)(6) hosp cancer center (b)(6).The caller states that her friend has two radiation burns on her clavicle area around her neck which was not a targeted treatment area.Reporter states that her friend questioned the tech and dr (b)(6) but, no one would tell her what the discolored and painful sites were on her neck."after several days in pain i took my friend to the emergency room and she was diagnosed with infection to her wounds and radiation burns." "one of her appts was canceled at the cancer center for device servicing; i wonder if the device was not operating properly and if she got too much of a radiation dose.".

• Brand Name: LINEAR ACCELERATOR
• Type of Device: LINEAR ACCELERATOR
• MDR Report Key: 8138929
• MDR Text Key: 129639684
• Report Number: MW5081897
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/05/2018

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?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 60 YR