MAUDE Adverse Event Report: MORGAN MEDESIGN, INC.; TABLE

Model Number FLT-M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 03/26/2019

Event Type  Injury  

Event Description

The patient was on endo table and fell off table and hit the floor.

• Type of Device: TABLE
• Manufacturer (Section D): MORGAN MEDESIGN, INC.; 947 piner place; santa rosa CA 95403
• MDR Report Key: 8775673
• MDR Text Key: 150553913
• Report Number: 8775673
• Device Sequence Number: 1
• Product Code: FSE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FLT-M
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 25550 DA