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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POSEY PRODUCTS LLC POSEY ECONOMY RESTRAINT HOLDER RESTRAINT, PROTECTIVE

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POSEY PRODUCTS LLC POSEY ECONOMY RESTRAINT HOLDER RESTRAINT, PROTECTIVE Back to Search Results
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 11/23/2020
Event Type  malfunction  
Event Description
This male patient with chronic cognitive impairment was admitted with severe sepsis of unclear source and altered mental status was admitted evening shift. Patient acutely confused and extremely restless and not sleeping at all. Initially in a roll vest and soft bilateral wrist restraints were placed on patient as patient constantly attempting to get out of bed and pulling at lines. Patient ripped though wrist restraint and pulled out iv. Torn restraint was removed and replaced with new one. Ripped restraint given to manager.
 
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Brand NamePOSEY ECONOMY RESTRAINT HOLDER
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY PRODUCTS LLC
272 east deerpath road
suite 206
lake forest IL 60045
MDR Report Key11002232
MDR Text Key221255354
Report Number11002232
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 12/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2020
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? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/10/2020
Event Location Hospital
Date Report to Manufacturer12/14/2020
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? No
Type of Device Usage Unkown

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