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

Model Number 2819

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Reinfusion (2403); Needle Stick/Puncture (2462)

Event Type  Injury  

Manufacturer Narrative

Customer confirmed the product will not be returning, therefore, this report is based solely on the information provided by the customer.Ongoing investigation is underway and results of investigation will be provided at a later time.Manufacturer reference file # (b)(4).Product will not be returning.

Event Description

Customer reported the patient is able to remove their iv's by grasping the items using their thumb and index finger customer reported there is too much room in the mitt where the patient is able to maneuver their fingers.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 road; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 8438065
• MDR Text Key: 139379098
• Report Number: 2020362-2019-00048
• 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: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2819
• Device Catalogue Number: 2819
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention