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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN RADIATION THERAPY; SYSTEM, RADIATION THERAPY

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UNKNOWN RADIATION THERAPY; SYSTEM, 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 26-february-2020, the patient reported to crc that he was hospitalized on (b)(6) 2020.Reported determine the patient was dehydrated.The patient received iv fluids, potassium, and magnesium.The patient was discharged to home in stable condition on (b)(6) 2020.
 
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Brand Name
RADIATION THERAPY
Type of Device
SYSTEM, RADIATION THERAPY
Manufacturer (Section D)
UNKNOWN
MDR Report Key9775299
MDR Text Key181949689
Report NumberMW5093436
Device Sequence Number1
Product Code MUJ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age71 YR
Patient Weight109
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