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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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MDR Report Key11378018
Report NumberCOR21000063-000
Device Sequence Number1
Product Code KPR
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this a Product Problem Report? No
Device Operator Other
Was Device Available for Evaluation? No Information
Patient Sequence Number1
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