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

Model Number MDT821301Q

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/31/2021

Event Type  malfunction  

Event Description

The rn (registered nurse) went to tighten up the strap, and it broke while attempting to do so (at the buckle).Manufacturer response for soft, non-violent wrist restraint, medline (per site reporter).According to our supply chain the manufacturer was responsive and said they would look into the matter.

• 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: 13076538
• MDR Text Key: 282722488
• Report Number: 13076538
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/04/2021

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: Health Professional
• Device Model Number: MDT821301Q
• Device Catalogue Number: MDT821301Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1