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U.S. Department of Health and Human Services

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

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E.M. ADAMS COMPANY E.M. ADAMS COMPANY SOFT LIMB HOLDER Back to Search Results
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".
 
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Brand NameE.M. ADAMS COMPANY
Type of DeviceSOFT 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 Key11424333
MDR Text Key235026480
Report Number1054786-2020-00001
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K971948
Number of Events Reported1
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 Received03/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number70806
Device Catalogue Number70806
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2020
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 Treatment Data
Date Received: 03/05/2021 Patient Sequence Number: 1
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