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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. QUICK RELEASE LIMB HOLDER RESTRAINT, PROTECTIVE

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MEDLINE INDUSTRIES, INC. QUICK RELEASE LIMB HOLDER RESTRAINT, PROTECTIVE Back to Search Results
Catalog Number MDT829090WQ
Device Problem Break (1069)
Patient Problem Emotional Changes (1831)
Event Date 01/26/2022
Event Type  Injury  
Event Description
Patient ultimately restrained and medication was given. Approximately 5-10 minutes after medication administration patient was still agitated and yelling. Patient had been restrained correctly but with one quick jerk of his right arm he was able to break the cuff piece of the restraint free from the ties that held the restraint to the bed. He was now able to swing his arm around and attempt to remove other restraints. Police had to be called again to restrain patient.
 
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Brand NameQUICK RELEASE LIMB HOLDER
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
one medline pl
mundelein IL 60060
MDR Report Key13391909
MDR Text Key284691433
Report Number13391909
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 Risk Manager
Type of Report Initial
Report Date 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Catalogue NumberMDT829090WQ
Device Lot Number84321020001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/26/2022
Event Location Hospital
Date Report to Manufacturer01/31/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/31/2022 Patient Sequence Number: 1
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