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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN DRUG/BIOLOGIC RADIATION THERAPY SYSTEM, SIMULATION, RADIATION THERAPY

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UNKNOWN DRUG/BIOLOGIC RADIATION THERAPY SYSTEM, SIMULATION, RADIATION THERAPY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Dehydration (1807)
Event Date 02/20/2020
Event Type  Injury  
Event Description
On (b)(6) 2020, the patient reported to crc that he was hospitalized on (b)(6) 2020. Reports determine the patient was dehydrated. The patient received iv fluids, potassium, and magnesium. The patient was discharged to his home in stable condition on (b)(6) 2020.
 
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Brand NameDRUG/BIOLOGIC RADIATION THERAPY
Type of DeviceSYSTEM, SIMULATION, RADIATION THERAPY
Manufacturer (Section D)
UNKNOWN
MDR Report Key9818366
MDR Text Key183517081
Report NumberMW5093669
Device Sequence Number1
Product Code KPQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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: 03/10/2020 Patient Sequence Number: 1
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