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

Model Number 2530

Device Problems Fail-Safe Problem (2936); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2022

Event Type  malfunction  

Event Description

Health care provider noticed the new type of posey restraints that they get are made of a slippery material.This material has the capability of coming lose after being tied to the bed frame, which can cause the patient to pull their lines or accidentally extubate themselves.

• Brand Name: POSEY
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS, LLC; 570 enterprise dr; neenah WI 54956
• MDR Report Key: 15713671
• MDR Text Key: 302850966
• Report Number: 15713671
• 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: 10/13/2022

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 Model Number: 2530
• Device Catalogue Number: 2530
• Device Lot Number: 2172T025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1