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

Catalog Number 2510

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 09/21/2021

Event Type  malfunction  

Event Description

Bilateral soft wrist restraints were placed on customer.Customer with periods of agitation, fight vent, kicking legs, grabbing at staff members and trying to shake it out.Restraint tore where the buckle attaches to the soft cloth.Immediate intervention to replace the broken/torn restraint with a new one was taken.No injury to patient or staff.

• Brand Name: POSEY ECONOMY LIMB HOLDER 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: 12568050
• MDR Text Key: 274529050
• Report Number: 12568050
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2510
• Device Lot Number: 1131T038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12775 DA