MAUDE Adverse Event Report: E.M. ADAMS, INC. E.M ADAMS CO, INC.; RESTRAINT, PROTECTIVE

Model Number 70806-1

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

Patient Problem Death (1802)

Event Date 06/01/2020

Event Type  Death  

Event Description

Patient snapped off restraints, jumped out of bed and went through the window.

• Brand Name: E.M ADAMS CO, INC.
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): E.M. ADAMS, INC.; 7496 commercial circle,; ft pierce FL 34951
• MDR Report Key: 10655205
• MDR Text Key: 210604768
• Report Number: 10655205
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 70806-1
• Device Lot Number: 07-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 18615 DA
• Patient Weight: 113