MAUDE Adverse Event Report: EXTERNAL BEAM RADIATION SYSTEM RADIATION THERAPY, CHARGED - PARTICLE, MEDICAL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fibrosis (3167)

Event Date 12/15/1987

Event Type  Injury  

Event Description

Radiation fibrosis syndrome with cervical radiation myelopathy post external beam radiation in 1987 for papillary thyroid metastasis. Fda safety report id# (b)(4).

• Brand Name: EXTERNAL BEAM RADIATION
• Type of Device: SYSTEM RADIATION THERAPY, CHARGED - PARTICLE, MEDICAL
• MDR Report Key: 8692851
• MDR Text Key: 147993105
• Report Number: MW5087308
• Device Sequence Number: 1
• Product Code: LHN
• 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: 06/07/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/11/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated By Manufacturer?

Is The Device Single Use?

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient TREATMENT DATA

Date Received: 06/11/2019 Patient Sequence Number: 1