MAUDE Adverse Event Report: E.M. ADAMS COMPANY E.M. ADAMS COMPANY; SOFT LIMB HOLDER

Model Number 70806

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

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

The complaint device was partial destroyed and was not available for evaluation.This report is based on customer provided information and images of bottom portion of the device.The cuff portion of the device was destroyed.The images showed the webbing strap of device failed just below the cuff.After reviewing all information, it was determined that the webbing strap failed due to excessive force applied by the patient.The application instructions for the device has contradictions indicating do not use on a patient who is or may become highly aggressive, combative or agitated.The medwatch report and discussion with the user show the patient to have acute delirium and displayed highly aggressive behavior.The cause of the break was result of not following the recommended application instructions.

Event Description

User fda 3500a report " patient snapped off restraints, jumped out of bed and went through the window".

• Brand Name: E.M. ADAMS COMPANY
• Type of Device: SOFT LIMB HOLDER
• Manufacturer (Section D): E.M. ADAMS COMPANY; 7496 commercial cricle; fort pierce FL 34951
• Manufacturer (Section G): E.M. ADAMS COMPANY; 7496 commercial circle; fort pierce FL 34951
• Manufacturer Contact: richard donahue ; 7496 commercial circle; fort pierce, FL 34951 ; 7724610532
• MDR Report Key: 11424333
• MDR Text Key: 235026480
• Report Number: 1054786-2020-00001
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K971948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70806
• Device Catalogue Number: 70806
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 51 YR
• Patient Weight: 113