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U.S. Department of Health and Human Services

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

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E.M. ADAMS, INC. E.M ADAMS CO, INC. RESTRAINT, PROTECTIVE Back to Search Results
Model Number 26-0647-1
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Irritation (1941)
Event Date 10/26/2020
Event Type  malfunction  
Event Description
Patient was restrained to the bed frame, and started to become agitated when he raised his arms and the restraint limb holder cuff tore from the nylon strap.
 
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Brand NameE.M ADAMS CO, INC.
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
E.M. ADAMS, INC.
7496 commercial circle
fort pierce FL 34951
MDR Report Key11055183
MDR Text Key241252751
Report Number11055183
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/10/2020,11/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number26-0647-1
Device Lot NumberHN 09-20
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/10/2020
Event Location No Information
Date Report to Manufacturer12/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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