MAUDE Adverse Event Report: TIDI PRODUCTS, LLC NON-LOCKING TWICE-AS-TOUGH ANKLE CUFF; RESTRAINT, PROTECTIVE

Model Number	2791
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
This report is based solely on the reported issue that the restraints do not work, and the patient can easily get out of them.Despite attempts for product return, the customer did not respond the due diligence emails and did not return call after leaving a voice mail.Without return of the device the reported issue could not be confirmed and without the device lot information the release documentation could not be reviewed.Historical review of the complaint database against the 2791 product revealed two similar reports for the last four years of unintentional patient release.Both products were not returned for evaluation.However, one of the customers provided video demonstration and was reviewed by tidi engineering.The failure was determined to be a known risk of this device that there is potential for this failure to occur if the product instructions for use (ifu) are not followed correctly.The other customer declined to return device.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 warnings 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 #2023-00089.Product not returned.
Event or Problem Description
The customer reported a complaint about product 2791.The customer stated that the restraints do not work, and the patient can easily get out of them.The date the issue was discovered is unknown, and no injury was reported.

• Brand Name: NON-LOCKING TWICE-AS-TOUGH ANKLE CUFF
• 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: 16440132
• Report Number: 2182318-2023-00008
• Device Sequence Number: 3150748
• Product Code: FMQ
• UDI-Device Identifier: 10190676002839
• UDI-Public: 10190676002839
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2023

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: 2791
• Device Catalogue Number: 2791
• 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: 01/26/2023
• Initial Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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