MAUDE Adverse Event Report: POSEY PRODUCTS LLC LOCKING TWICE-AS-TOUGH CUFFS; RESTRAINT, PROTECTIVE

Model Number 2799

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product was requested to be returned and has not been received.This report is based solely on the customer reported issue.The customer has reported issues with engaging the restraints related to the locking twice as tough cuffs, specifically part number 2799.In particular, the customer has reported that the restraint appears to be loose in the ankles.There have been many reports of twice as tough cuffs with difficulty closing and locking the lock due to increased thickness of the webbing material in the straps post laundering.This is a known issue that is being handled internally via capa.A review of the complaint history for this product identified no other complaints of the restraint being loose in the ankle area or otherwise.The instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.A capa has been created to address the issue of difficulty closing and locking the buckles.No further corrective or preventative actions are necessary at this time.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.(b)(4).

Event Description

Customer reported issues with engaging the restraints (2799).In particular, the restraint appears to be loose in the ankles.Troubleshooting form has been saved.Customer has put in place a replacement restraint at this time.The date the issue was discovered is unknown and no patient incident or injury was reported.

• Brand Name: LOCKING TWICE-AS-TOUGH CUFFS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 entrprise drive; neenah, WI 54956 ; 6264433143
• MDR Report Key: 9434006
• MDR Text Key: 190970515
• Report Number: 2020362-2019-00218
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2799
• Device Catalogue Number: 2799
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1