MAUDE Adverse Event Report: POSEY PRODUCTS LLC MITTS- NO FINGER SEPARATORS; RESTRAINT, PROTECTIVE

Model Number 2811

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Extubate (2402)

Event Type  Injury  

Manufacturer Narrative

The customer confirmed they will not be returning the device.This event is reported solely on the information provided by the customer.Historical review of the complaint database found 4 other event with similar issue where the patients were able to maneuver around the mitts.Of the 4 complaints, product was returned for only one of the complaint.Analysis of the device found it to have met specifications and functioned as designed.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.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 will not be returning.

Event Description

Customer reported patient was able to remove the mitts resulting in unplanned self-extubation.Additional information from the customer stated she do not believe the issue is related to any specific product failure.The date the issue was discovered is unknown.

• Brand Name: MITTS- NO FINGER SEPARATORS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck rd; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 8502389
• MDR Text Key: 141563445
• Report Number: 2020362-2019-00080
• 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: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2811
• Device Catalogue Number: 2811
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2019
• 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
• Patient Outcome(s): Other