MAUDE Adverse Event Report: Young Innovations

Device Problem Device Operational Issue (2914)

Patient Problem Radiation Exposure, Unintended (3164)

Event Type  malfunction  

• 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 Key: 7947138
• Report Number: COR18001610-000
• Device Sequence Number: 1
• Product Code: EHD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/08/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/08/2018
• Is this a Product Problem Report?: Yes
• 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