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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Young Innovations
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Device Problem Device Operational Issue (2914)
Patient Problem Radiation Exposure, Unintended (3164)
Event Type  malfunction  
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Manufacturer (Section G)
Young Innovations
4321 goshen road
fort wayne IN 46818
Manufacturer Contact
tammy shiffler
4321 goshen road
fort wayne, IN 46818
8006542027
MDR Report Key8386279
Report NumberCOR19000122-000
Device Sequence Number1
Product Code EHD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 03/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2019
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No Information
Patient Sequence Number1
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