MAUDE Adverse Event Report: TIDI PRODUCTS LLC SELF-REALEASING ROLL BELT; RESTRAINT, PROTECTIVE

Model Number	1135
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
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.Customer reported having two different versions of the instructions for use (ifu) with inconsistencies in the contraindications section.It was confirmed the customer has the current version of document (b)(4) and the previous version.In the current version of the ifu, there are no contraindications listed as in the previous version.The previously listed contraindications were not removed from the ifu but were reworded and moved to the warnings sections.The ifu instructs staff to perform a clinical assessment of their patient on whether or not the restraint is safe.If a patient cannot follow instructions, they likely cannot demonstrate they know how to self-release from the product and the decision to use it as a restraint or remove the product would be a clinical decision on if it is safe.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.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 warranted.Manufacturer reference file (b)(4).
Event or Problem Description
Mdr report received from fda.Customer report# mw5170531.It was reported the posey self release roll belt have inconsistent instructions in the box.Not all of the boxes include contraindications.According to the ifu, these style belts may present a patient safety risk if used with patients that are unwilling or unable to follow directions/instructions.

• Brand Name: SELF-REALEASING ROLL BELT
• 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: 22346516
• Report Number: 2182318-2025-00066
• Device Sequence Number: 8520089
• Product Code: FMQ
• UDI-Device Identifier: 10190676003362
• UDI-Public: 10190676003362
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 06/03/2025

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: 1135
• Device Catalogue Number: 1135
• Device Lot Number: UNKNOWN
• 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: 06/03/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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