MAUDE Adverse Event Report: TIDI PRODUCTS 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
Additional Manufacturer Narrative
Customer confirmed the product will not be returning for analysis.Therefore, this event is reported based on the information provided by the customer and from historical data of similar complaints.Historical review of the complaint database revealed two other complaints where beads were coming out of the mitts.Of the 2 complaints product was either not returned or a root cause could not be determined.There was no serious injury reported in either cases.Customer confirmed they are no longer in use with the part 2810 and have switched to the posey double secure mitts.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.Without the return of the device, the reported issue could not be confirmed and without the device lot information, the release documentation could not be reviewed.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 warning 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 warrant.Manufacturer reference file (b)(4).
Event or Problem Description
Customer reported to tm that the mitts are splitting open and could potentially cause harm to the patients if the beads are swallowed.They mentioned the patients are clawing through them and biting the mitts, but are concerned about the damage from these mitts.

• Brand Name: MITTS - NO FINGER SEPARATORS
• Common Device Name: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise dr; neenah CA 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 15588600
• Report Number: 2182318-2022-00117
• Device Sequence Number: 7142078
• Product Code: FMQ
• UDI-Device Identifier: 10190676005380
• UDI-Public: 10190676005380
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/12/2022

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: 2810
• Device Catalogue Number: 2810
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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