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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL INDUSTRIES MEDICAL SOFT RESTRAINED RESTRAINT, PROTECTIVE

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DEROYAL INDUSTRIES, INC. DEROYAL INDUSTRIES MEDICAL SOFT RESTRAINED RESTRAINT, PROTECTIVE Back to Search Results
Device Problem Break (1069)
Patient Problem Emotional Changes (1831)
Event Date 09/05/2019
Event Type  Injury  
Event Description
Pt became agitated and broke bilateral medical soft wrist restraints. Fda safety report id# (b)(4).
 
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Brand NameDEROYAL INDUSTRIES MEDICAL SOFT RESTRAINED
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
DEROYAL INDUSTRIES, INC.
powell TN 37849
MDR Report Key9069925
MDR Text Key158827369
Report NumberMW5089792
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/11/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/13/2019 Patient Sequence Number: 1
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