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

Model Number 2530

Device Problem Product Quality Problem (1506)

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

Event Date 11/02/2023

Event Type  malfunction  

Event Description

Customer reporting complaint on product # 2530.Customer states that the strap material is too thin to hold a slip knot.Patients are able to easily remove the restraint.

Manufacturer Narrative

H3 product is not available for return or evaluation.Therefore, this report is based solely on the information provided by the customer.A review of the complaint database revealed one other instance similar to this event in the past two years.Product was not returned for this complaint, therefore root cause could not be determined.Investigation confirmed there have been no changes to material configuration for the webbing or changes to the supplier.Application instructions state triangulation process; to restrict patient¿s range of motion: separate the straps and attach at different points along the frame that moves with the patient out of the patient¿s reach, using quick-release ties (do not attach to side rail or head/footboard).Warnings state 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.Additional or different body or limb restraints may be needed if the patient pulls violently against the bed straps.To reduce the risk of the patient getting access to the line/wound/tube site.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, 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.Fda medwatch report (b)(4) / manufacturer reference file (b)(4).

• Brand Name: FOAM LIMB HOLDER
• 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: 18959682
• MDR Text Key: 339337516
• Report Number: 2182318-2024-00033
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 10190676002884
• UDI-Public: 10190676002884
• 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: 02/22/2024

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: 2530
• Device Catalogue Number: 2530
• Device Lot Number: 3185T068
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2023
• 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