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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 Key7847981
Report NumberCOR18001454-000
Device Sequence Number1
Product Code REU
Combination Product (Y/N)
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 08/29/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/04/2018
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