MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. QUICK RELEASE LIMB HOLDER; RESTRAINT, PROTECTIVE

Catalog Number MDT829090WQ

Device Problem Break (1069)

Patient Problem Emotional Changes (1831)

Event Date 01/26/2022

Event Type  Injury  

Event Description

Patient ultimately restrained and medication was given.Approximately 5-10 minutes after medication administration patient was still agitated and yelling.Patient had been restrained correctly but with one quick jerk of his right arm he was able to break the cuff piece of the restraint free from the ties that held the restraint to the bed.He was now able to swing his arm around and attempt to remove other restraints.Police had to be called again to restrain patient.

• Brand Name: QUICK RELEASE LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 13391909
• MDR Text Key: 284691433
• Report Number: 13391909
• 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: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MDT829090WQ
• Device Lot Number: 84321020001
• 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: 01/26/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 10585 DA
• Patient Sex: Male
• Patient Weight: 77 KG