MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; RESTRAINT, PROTECTIVE

Model Number MDT821301QL

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

Patient Problem Irritability (2421)

Event Date 07/21/2022

Event Type  malfunction  

Event Description

Patient in bilateral wrist restraints.When becoming agitated and pulling on the restraint, the release buckle became undone, allowing patient to use his arms freely and grab at equipment/hit staff.After reapplying the restraint, the patient was able to do this again and get out of his wrist restraint.Rn got another set of restraints and same issue occurred.Manufacturer response for restraint, protective, medline (per site reporter) unknown.

• Brand Name: MEDLINE
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15174014
• MDR Text Key: 297325869
• Report Number: 15174014
• 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: 08/02/2022

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 Model Number: MDT821301QL
• Device Catalogue Number: MDT821301QL
• Device Lot Number: 33022030001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male