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

Model Number	2530
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• 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: 18959682
• Report Number: 2182318-2024-00033
• Device Sequence Number: 4580149
• Product Code: FMQ
• UDI-Device Identifier: 10190676002884
• UDI-Public: 10190676002884
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2023
• 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