MAUDE Adverse Event Report: TIDI PRODUCTS 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

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 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
• Type of Device: 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
• MDR Text Key: 301594276
• Report Number: 2182318-2022-00117
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 10190676005380
• UDI-Public: 10190676005380
• 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: 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
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/12/2022
• 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