MAUDE Adverse Event Report: TIDI PRODUCTS LLC SELF-RELEASING STATIONARY BELTS -BEDS /CHAIRS; RESTRAINT, PROTECTIVE

Model Number	4126Q
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is based solely on the information provided by the customer.Product is not available for return, therefore, confirmation of complaint and the root cause could not be determined.A review of the complaint database did not reveal any adverse events for sku 4126q.Customer stated patient had been in the restraint for a week and was not combative or agitated.The patient did not sustain any injuries or require medical intervention as a result of the break.An image of the damaged product was provided by the customer.Based on the image, it appears to be a different sku than what was originally reported.Communication has been sent to the customer to confirm the correct part number involved in the incident and if available to send a sample product for evaluation.A device history record (dhr) of the affected lot number 5098t224 showed lot is for part 8399 disposable chair alarm belt.The dhr did not reveal any issues that could have contributed to the reported incident.No ncrs were identified.The product passed all verification testing and met manufacturing specifications prior to being released for distribution.Historical review of the complaint database for part 8399 revealed similar instances where the belt ripped at the seams.Of the products returned, investigation revealed user error as the foam materials of the returned sensor belts were being torn apart due to excessive force.The instructions for use (ifu) was reviewed and was found to provide adequate instructions and warnings for safe and effective use of the device.The instructions for use state do not use on a patient who is or becomes highly aggressive, combative, or agitated.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.Dispose of damaged products per facility policy for biohazardous material.Without the return of the device, the part number or the reported issue could not be confirmed.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 reporting a complaint on product (b)(4) self releasing seat belt lot 5098t224.Customer states that the self releasing seat belt ripped in half leading to a patient fall.Report does not state any injuries or death as a result of the fall.

• Brand Name: SELF-RELEASING STATIONARY BELTS -BEDS /CHAIRS
• 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: 22850020
• Report Number: 2182318-2025-00080
• Device Sequence Number: 20937978
• Product Code: FMQ
• UDI-Device Identifier: 10190676003485
• UDI-Public: 10190676003485
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 07/28/2025

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: 4126Q
• Device Catalogue Number: 4126Q
• Device Lot Number: 5098T224
• 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: 07/28/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2025
• 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 Age: 82 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic