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

Model Number 2790Q

Device Problem Structural Problem (2506)

Patient Problem Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Product is scheduled to be returned, but has not been received by manufacturer at the time of this report.Therefore, this report is based solely on the information provided by the customer.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 provided adequate instructions and warning for the safe and effective use of the device.Therefore, no corrective or preventive 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.(b)(4).Product expected, but not yet received.

Event Description

Customer is reporting an issue regarding item 2790q (wrist restraint).Patient was able to unlock himself, staff physician was punched in the process.They suspect the restraints may have been applied incorrectly, requested sales rep for further training and evaluations.The date the event occurred is unknown.

• Brand Name: QUICK-RELEASE TWICE-AS-TOUGH CUFFS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck road; arcadia 91006
• Manufacturer Contact: chris rahn ; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 9124958
• MDR Text Key: 161309810
• Report Number: 2020362-2019-00187
• 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: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2790Q
• Device Catalogue Number: 2790Q
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2019
• 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