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 Date 08/27/2022

Event Type  malfunction  

Manufacturer Narrative

Product is not available for return or evaluation.Therefore, this report is based solely on the information provided by the customer and historical data.The product lot number was not provided, therefore, a review of the device history record could not be performed.Historical review of the complaint database revealed three other complaints where beads were coming out of the mitts.Of the 3 complaints product was either not returned or a root cause could not be determined.There were no serious injuries reported in either of the cases.Customer reported the patient bit through the mitts causing the beads to be exposed.The ifu contraindications state do not use on a patient who is or becomes highly aggressive, combative, agitated, or suicidal.Warnings state that additional or different body or limb restraints may be needed.Customer confirmed they are no longer in use with the part 2810 and have transferred back to using 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.Fda report 0506030000-2022-8001 / manufacturer reference file (b)(4).Product not returned.

Event Description

Customer reported via email the patient bit through her mittens sending beads everywhere in a patient that was at risk of aspiration.This was the 3rd reported incident with the mitts tearing or breaking causing beads to be exposed to patient.

• Brand Name: MITTS - NO FINGER SEPARATORS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise dr; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 15633988
• MDR Text Key: 306908662
• Report Number: 2182318-2022-00122
• 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: 09/19/2022

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: 09/19/2022
• Initial Date FDA Received: 10/19/2022
• 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
• Patient Sex: Female