MAUDE Adverse Event Report:; DIAGNOSTIC ULTRASOUND DEVICE

Device Problem Material Frayed (1262)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This report is resubmitted on request by the fda to correct field to initial report.

Event Description

Previously submitted.

• Type of Device: DIAGNOSTIC ULTRASOUND DEVICE
• MDR Report Key: 6298948
• MDR Text Key: 193969717
• Report Number: 3009498591-2016-00673
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1