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U.S. Department of Health and Human Services

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

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EXTERNAL BEAM RADIATION SYSTEM RADIATION THERAPY, CHARGED - PARTICLE, MEDICAL Back to Search Results
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).

 
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Brand NameEXTERNAL BEAM RADIATION
Type of DeviceSYSTEM RADIATION THERAPY, CHARGED - PARTICLE, MEDICAL
MDR Report Key8692851
MDR Text Key147993105
Report NumberMW5087308
Device Sequence Number1
Product Code LHN
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received06/11/2019
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
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