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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POSEY PRODUCTS LLC ROLL JACKET RESTRAINT RESTRAINT, PROTECTIVE

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POSEY PRODUCTS LLC ROLL JACKET RESTRAINT RESTRAINT, PROTECTIVE Back to Search Results
Catalog Number 3320L
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 11/09/2020
Event Type  malfunction  
Event Description
Difficult to manage patient who was acting out aggressively and was agitated. Nurse contacted security for assistance with the patient. Security and nursing in patient's room when the patient grabbed the roll jacket and ripped it. Security assisted nursing with applying a new roll jacket. Patient had been in roll jacket since admission seven days prior. Patient's bilateral soft wrist restraints were discontinued three days prior to event.
 
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Brand NameROLL JACKET RESTRAINT
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY PRODUCTS LLC
272 east deerpath road suite 206
lake forest IL 60045
MDR Report Key10867634
MDR Text Key217136065
Report Number10867634
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 11/16/2020,11/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3320L
Device Lot Number0246T430
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/16/2020
Event Location Hospital
Date Report to Manufacturer11/19/2020
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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