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

Model Number 2794

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2019

Event Type  malfunction  

Manufacturer Narrative

Customer confirmed the product was discarded and they will not be returning.Therefore, this complaint is based solely on the customer reported issue.Additional customer feedback is currently pending.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Instructions for use indicate; not to use this device on a patient who is or becomes; highly aggressive or combative; self-destructive; or deemed to be an immediate risk to others, unless the patient is under constant supervision.Instructions for use also indicate; severe psychological, or physical problems may occur: if the applied device is uncomfortable; or if it severely limits movement.If the patient is likely to cause injury to him/herself or others, get help from a qualified medical authority to find alternate intervention or method of restraint.Therefore, no corrective or preventative actions are necessary.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.Manufacturer reference file #(b)(4).Product was discarded.

Event Description

Customer reported an adolescent patient somehow got her arms behind her back and above her head.The nurse attempted to reapply the restraint and a spring on the lock broke free and would not re-lock.The patient was not injured but the nurse was injured.The extent of the nurse's injury is currently unknown.

• Brand Name: CONNECTED TWICE-AS-TOUGH CUFFS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck road; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 8446464
• MDR Text Key: 139705666
• Report Number: 2020362-2019-00049
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2794
• Device Catalogue Number: 2794
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2019
• 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: N
• Patient Sequence Number: 1