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

Model Number	2551
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Please share this with the complaint evaluators: i discussed tying a knot just below the qr buckle per ifu.The nurse manager's response was "what is the point of the buckle? which is completely understandable.She said that would not work because they must untie it often to adjust the length to accommodate the patients position in the bed.I, then, suggested a slip knot for quick release.She said that would never happen.As a third option, i suggested utilizing the inner loop on the detachable piece to shorten the strap, adjusting the angle of the qr to help prevent slippage.
Additional Manufacturer Narrative
H3 the reported issue of slippage was not confirmed.Evaluation of the returned product found when following the steps prescribed in the ifu, the bed connecting straps did not exhibit any slippage.Step 1b on the ifu application instructions states in order to limit unwanted adjustment, tie an overhand knot with the excess strap directly below the quick release buckle.Since no device design or manufacturing defect could be confirmed, the probable causes of the complaint could be improper application of the device.The instructions for use 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 the straps to ensure a good connection.To limit unwanted adjustment, tie an overhand knot with the excess strap directly below the quick-release buckle.Contraindications in the ifu state do not use this device with someone who has continued highly aggressive or combative behavior, self-destructive behavior, or deemed to be an immediate risk to others or to self.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 warranted.Manufacturer reference file (b)(4).

• Brand Name: LIMB HOLDER
• 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: 17586699
• Report Number: 2182318-2023-00075
• Device Sequence Number: 12023258
• Product Code: FMQ
• UDI-Device Identifier: 10190676004956
• UDI-Public: 10190676004956
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K963413
• 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): 07/24/2023

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: 2551
• Device Catalogue Number: 2551
• Device Lot Number: 3013T003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• 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