MAUDE Adverse Event Report: TIDI PRODUCTS MESH PEEK A BOO MITT; RESTRAINT, PROTECTIVE

Model Number 2825

Device Problem Unintended Movement (3026)

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

Event Type  malfunction  

Event Description

Customer contacted tm via email to report incident.Patient was able to turn their hand around inside the mitt and dislodge an internal tub.Ifu was followed as written.No injuries occurred.No gtin number provided.

Manufacturer Narrative

This report is based solely on the information provided by the customer.Confirmation of the customer's complaint and the root cause could not be determined without the return of the product.Historical review of the complaint database did not reveal any similar events against part 2825 where the patient was able to maneuver around the mitts to remove tubes.The customer has confirmed they switched back to the previously used posey mitt with padding on both sides of the mitt.Customer determined the mesh mitts were not safe with their patient population.The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu states, never alter or repair this product.Always inspect before each use: check for broken stitches or parts; torn, cut or frayed material; or locks, buckles, or hook-and-loop fasteners that do not hold securely.Do not use soiled or damaged products.Doing so may result in serious injury or death.Do not use this device with someone who has continued highly aggressive or combative behavior, self-destructive behavior, is deemed to be an immediate risk to themselves or to others.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 not returned.

• Brand Name: MESH PEEK A BOO MITT
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 14847587
• MDR Text Key: 298307779
• Report Number: 2182318-2022-00068
• 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: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2825
• Device Catalogue Number: 2825
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/28/2022
• 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