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

Model Number	2810
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer is reporting a complaint on product # 2810.Customer states that a patient was able to scratch and then pull away the inner lining at the stitching seam to expose the foam balls that are inside the mitt.
Additional Manufacturer Narrative
H6: evaluation codes.The evaluation found an internal seam separation about 4 inches long causing the polystyrene beads to escape.Historical complaint database has been reviewed for the last 2 years revealed five other complaints where beads were coming out of the mitts.All products were not returned for evaluations.Four of the complaints were reported that the patients bit the products causing foam beads to escape, and one complaint could not be determined where the failure originated as it was not returned for evaluation.There was no serious injury reported in either of the cases.For this reason, none of the historical complaints were directly related to the internal seam separation leading to this complaint as an isolated event.Subsequently, the qa department at the mexico facility was notified of the internal seam separation to prevent the issue from recurring.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 indicates 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 may be 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 corrective and 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.Reference manufacturer file number (b)(4).

• Brand Name: MITTS - NO FINGER SEPARATORS
• Common Device Name: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 17970216
• Report Number: 2182318-2023-00097
• Device Sequence Number: 7670554
• Product Code: FMQ
• UDI-Device Identifier: 10190676005380
• UDI-Public: 10190676005380
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K963413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2023

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: 2810
• Device Catalogue Number: 2810
• Device Lot Number: 3102T018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown