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

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.

• Brand Name: ROLL JACKET RESTRAINT
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 272 east deerpath road suite 206; lake forest IL 60045
• MDR Report Key: 10867634
• MDR Text Key: 217136065
• Report Number: 10867634
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3320L
• Device Lot Number: 0246T430
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12775 DA
• Patient Weight: 213