MAUDE Adverse Event Report: POSEY PRODUCT UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF, LARGE; RESTRAINT, PROTECTIVE

Model Number 2700QL

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation results: visual findings observed the box stitch for the bed connecting strap is broken causing the product to come apart.Evaluation confirmed the reported issue.The box stitch on the top and the bottom are intact, but the threads in-between have loosened or broken resulting in failure.The root cause could not be determined only suggested possible causes such as product applied to a combative patient who exerted enough force beyond the threshold of the stitching to cause failure, or incorrect sewing machine settings causing a loose or tight box stitch.All complaints are trended and reviewed by management on a monthly basis.As a part of the monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.No corrective or preventative actions are necessary at this time.Manufacturer reference file # (b)(4).

Event Description

Customer reporting the stitching securing the strap and buckle broke.Giving patient more range of motion to potentially injury themselves, or others.Customer reported via email.The date the issue was discovered is unknown and no patient incident or injury was reported.

• Brand Name: UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF, LARGE
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCT; 2530 lindsay privado drive; unit a; ontario CA 91761
• Manufacturer Contact: chris rahn ; 570 enterprise dr; neenah, WI 54956 ; 9207514300
• MDR Report Key: 11724593
• MDR Text Key: 247344474
• Report Number: 2020362-2021-00021
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2700QL
• Device Catalogue Number: 2700QL
• Device Lot Number: 8214T086
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1