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

Model Number 2791Q

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 07/02/2020

Event Type  malfunction  

Event Description

Patient placed in posey violent restraints by nurses and security.What happened: patient removed restraint on left wrist and was kicking feet, right ankle restraint broke loose.What should have happened: restraint shouldn't have broken and patient shouldn't have been able to remove left wrist restraint as easily.This effected the patient: because it required security and multiple rns to enter patient room again and replace restraints.

• Brand Name: POSEY VIOLENT RESTRAINTS.
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS, LLC; 272 east deerpath road; suite 206; lake forest IL 60045
• MDR Report Key: 10791729
• MDR Text Key: 214803267
• Report Number: 10791729
• 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: 10/28/2020

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 Model Number: 2791Q
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2020
• Date Report to Manufacturer: 11/05/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14600 DA