MAUDE Adverse Event Report: DJO, LLC PROCARE QUICK RELEASE LIMB HOLDER; RESTRAINT, PROTECTIVE

Model Number 79-91400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Confusion/ Disorientation (2553)

Event Date 05/21/2019

Event Type  malfunction  

Event Description

This writer notified of person down via overhead page to room.On arrival, found patient on floor with multiple nurses around patient.Patient is bleeding from left arm from what appears to be an iv site that was removed.Patient is confused and combative with staff and resisting attempts to be assisted back to bed.Patient's spouse is also in room, standing, and combative with staff and appears to be confused as well.Spouse states numerous times "all of you need to get out of my house!" and then slaps the nursing staff that are attempting to care for patient.This writer moves between spouse and nursing staff to prevent further impacts.Security then moves to same position and continues to prevent spouse from touching medical staff; however, spouse continues to be disruptive from apparent confusion and does not appear to be oriented to place or time.Patient assisted back to bed by nursing staff and telephone order obtained to place restraints for safety as well as ct head to assess for possible injury from fall.Of important note: during time that medical restraints were being applied the restraint product that was on the floor presented numerous challenges to nursing staff due to its design that prevented its easy application.On numerous attempts, the restraint was wrapped around the wrist and the velcro failed to hold and allowed the patient's arm to become free.This writer strongly suggests changing medical restraint product to one with better performance and that reliably hold when velcro is applied.Restraint product on unit is "procare quick release limb holder 79-91400.".

• Brand Name: PROCARE QUICK RELEASE LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): DJO, LLC; 1430 decision st; vista CA 92081
• MDR Report Key: 9995175
• MDR Text Key: 188827392
• Report Number: 9995175
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 79-91400
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31755 DA