MAUDE Adverse Event Report: TIDI PRODUCTS LLC FOAM LIMB HOLDER; 2532; RESTRAINT, PROTECTIVE

Model Number	2532
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was received and evaluated.Visual findings observed the restraints appear normal, with no damage observed on the foam, straps, hook-and-loop (velcro) fasteners, or buckles.The straps were flat, with no indentation, creasing, or wrinkling typically associated with a strap that has been tied for an extended period.Evaluation found when the application instructions prescribed in the ifu were followed, the restraints did not exhibit slippage issue indicating the product is functional and will perform as intended.Based on the condition of the returned restraints and the results of the functional testing, it can be determined that the likely root cause of the reported patient escape is improper application.Specifically, the overhand knot may not have been tied in the excess strap material, and/or the male-clip strap may not have been twisted prior to engaging the buckle.Failure to follow these ifu-required steps could allow the strap to slip, enabling the patient to escape.The ifu application instructions state to attach the female end of the quick-release buckle (short strap) to the frame that moves with the patient, out of the patient¿s reach (do not attach to side rail or head/footboard).You may also wrap the connecting strap once around the frame to move the buckle out of the patient¿s reach.Secure by feeding the female end through the loop in the strap.Insert the male end of the connecting strap into the female end of the short strap.Listen for a snapping sound, pull firmly on straps to ensure a good connection.To limit unwanted adjustment, tie an overhand knot with the excess strap directly below the quick-release buckle.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
Customer reporting complaint on product#: 2532.The customer states that the patient was able to free themselves from the restraint.Lot#: 3293t027.This was due to a clip failure it is stated.

• Brand Name: FOAM LIMB HOLDER; 2532
• 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: 24261035
• Report Number: 2182318-2026-00004
• Device Sequence Number: 15447644
• Product Code: FMQ
• UDI-Device Identifier: 10190676004789
• UDI-Public: 10190676004789
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 01/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 2532
• Device Catalogue Number: 2532
• Device Lot Number: 3293T027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• 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