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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:

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Device Problem Device Operational Issue (2914)
Patient Problem Radiation Exposure, Unintended (3164)
Event Type  No Answer Provided  
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  New Search  |  Submit an Adverse Event Report

MDR Report Key11416117
Report NumberCOR21000070-000
Device Sequence Number1
Product Code KPR
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 03/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2021
Is this a Product Problem Report? No
Device Operator Other
Was Device Available for Evaluation?
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No Answer Provided
Type of Device Usage Invalid Data

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