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

Model Number 2793

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Customer reported via email, they had a patient who was able to tear the cuff.Customer no longer has this product, only provided a photo.

Manufacturer Narrative

This report is based solely on the information provided by the customer.Due to product not being returned, reported issue cannot be determined with only the information available.A historical review of the complaint database for part 2793, did not find any other similar complaint.At this time, there is no manufacturing non-conformity found.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu states before each use, check cuffs and straps for cracks, tears, and/or excessive wear or stretch, broken buckles or locks, and/or that hook-and-loop adheres securely as these may allow patient to remove cuff.Discard if device is damaged or if unable to lock.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 (ifu) 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 warrant.Manufacturer reference file (b)(4).Product not returned.

• Brand Name: LOCKING TWICE-AS-TOUGH CUFFS ANKLE
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise dr; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 14932711
• MDR Text Key: 298308098
• Report Number: 2182318-2022-00076
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2793
• Device Catalogue Number: 2793
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1