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

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.

• Brand Name: POSEY ECONOMY RESTRAINT 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: 11002232
• MDR Text Key: 221255354
• Report Number: 11002232
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Weight: 113