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

Model Number 2810

Device Problem Material Frayed (1262)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The evaluation found an internal seam separation about 3 inches long causing the polystyrene beads to escape.Historical data has been reviewed for the last 2 years showed only one other complaint involving beads spilling out.However, there was no serious injury documented with that complaint and product was not returned.The instructions for use were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.The instruction for use (ifu) on this product indicate to do not use on a patient who is or becomes highly aggressive, combative, agitated, or suicidal.The warning section stated additional or different body or limb restraints maybe needed to reduce the risk of the patient getting access to the line/wound/tube site; to prevent the patient from flailing or bucking up and down and causing self-injury.Therefore, no correct 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).

Event Description

On (b)(6) 2021 (b)(6) the customer contacted us via e-mail.The customer has a 2nd instance of a mitt leaking foam beads.Customer states "we have been trialing the new mittens on 5th and we are having an issue with them.Below is a picture of the 2nd time we have the beads that are on the padded side of the mitten come out of the mitten and all over the patient and the bed.When we look inside the mitten, we cannot really tell where the opening is, but it seems to happen after the mittens have been on the patient.Both of the patients this happened with are not combative or moving around a lot.We're not sure if by the patient moving their hand around in the mitten it somehow creates a tear or opening that then allows the beads to come out.Needless to say, this doesn't seem like it would be a good product going forward.I have this particular mitten in my office if anyone wants to see it." a ts template has been created and saved to the drive.No gtin or lot #'s were made available.

• Brand Name: MITTS - NO FINGER SEPARATORS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS, LLC; 2530 lindsay privado drive; ontario CA 91761
• MDR Report Key: 11996913
• MDR Text Key: 280758529
• Report Number: 2020362-2021-00036
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2810
• Device Catalogue Number: 2810
• Device Lot Number: 1018T105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1