MAUDE Adverse Event Report: TIDI PRODUCTS LLC TAT LIMB HOLDER;2789Q; RESTRAINT, PROTECTIVE

Model Number	2789Q
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Abrasion (1689)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reporting complaint on the product 2798q.Customer states that product broke while a patient was using it.As a result a staff member was injured.There are no details included about the nature of the injury or the situation of the patient.Just that there was a failure and a staff member was hurt.
Additional Manufacturer Narrative
Product was returned and evaluated.Visual findings observed one restraint received.The cuff is in like-new condition, with no visible signs of wear or damage.The velcro is intact and functional, showing good adhesion.Webbing is in good condition, with no fraying, tears, or defects observed.Straps are in good condition and appear fully usable.The male end clip on the bed connecting strap is broken, and the female end of the quick-release buckle (short strap) is missing.Evaluation found that the clip that gets secured around the cuff, is intact and functions as intended.The male end clip for strap that attaches to the bed is broken, which affects the functionality of the product.A tidi representatives communication with the facility found that the staff injury was a scratch from the patient.Additionally, when part 2789q was sinched to restrain the patients wrist, the strap buckle was close to the patients cuffed wrist and the patient was able to break and unlatch the buckle.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The application instructions state: 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.Warnings state: some patients may require additional interventions in conjunction with a restraint in order to prevent injury to self or others.1.If the patient pulls violently against the bed straps.2.To reduce the risk of the patient getting access to the line/wound/tube site.3.To prevent the patient from flailing or bucking up and down and causing self injury.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).

• Brand Name: TAT LIMB HOLDER;2789Q
• 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: 25032494
• Report Number: 2182318-2026-00044
• Device Sequence Number: 10260826
• Product Code: FMQ
• UDI-Device Identifier: 10190676003195
• UDI-Public: 10190676003195
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/31/2026

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: 2789Q
• Device Catalogue Number: 2789Q
• Device Lot Number: 5353T012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2025
• 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 Sex: Unknown