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

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 06/16/2020

Event Type  malfunction  

Event Description

Patient displaying increased agitation.Multiple security officers were in the room, along with police officer and multiple nursing staff.The patient was verbally abusive towards the staff.Patient started to pull and rock on the bedside rails and he was able to break through the soft wrist restraints (bilateral soft wrist restraints started for prevention of pulling out life sustaining ivs and tubing.Patient was placed in metal handcuffs.Broken restraint was sent to the quality department.

• Brand Name: POSEY ECONOMY LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 272 east deerpath road suite 206; lake forest IL 60045
• MDR Report Key: 10167030
• MDR Text Key: 195553459
• Report Number: 10167030
• 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: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9855 DA
• Patient Weight: 25