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

Model Number 2798

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

H3 this report is based solely on the information provided by the customer.Customer confirmed staff injuries but did not specify the type of injury sustained.A review of the complaint database found similar complaints for this device in the past two years.Of those returned and evaluated some potential causes are wear and tear of the buckle, and straps swelling causing buckles to be difficult to lock due to improper laundering.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 to 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.The ifu also provided extra warning to 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.Laundering instructions state fasten all buckles and locks to reduce risk of damage during wash and dry cycles.Do not put buckles or locks through extractors.For maximum life, launder in a laundry bag.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.Historical data revealed some potential causes from similar issues reported and evaluated; however, none can be confirmed without the return 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).

Event Description

Customer reporting a complaint on product # 2798 lot#3305t029 restraint.A staff member was injured trying to close the 2798 restraint.Which resulted in the staff member having to miss time from work.This incident occured several weeks ago and the customer does not have the original product that was involved in the incident.

• Brand Name: LOCKING TWICE-AS-TOUGH CUFFS
• Type of Device: 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: 18970874
• MDR Text Key: 339002975
• Report Number: 2182318-2024-00034
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 10190676002709
• UDI-Public: 10190676002709
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 02/26/2024

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: 2798
• Device Catalogue Number: 2798
• Device Lot Number: 3305T029
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1