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

Model Number 2532

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

H3 customer confirmed the product will not be returning for analysis.Therefore, this report is based on the information provided by the customer.Communications with the customer reported the issue was believed to be due to user error and no other issues were reported.A review of the device history record did not reveal any non-conformances or anomalies related to the lot number associated with this complaint, product passed all testing prior to release for distribution.Instructions for use (ifu) warning 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.The ifu application instructions state to attach the female end of the quick-release buckle (short strap) to the frame that moves with the patient, out of the patient¿s reach (do not attach to side rail or head/footboard).You may also wrap the connecting strap once around the frame to move the buckle out of the patient¿s reach.Secure by feeding the female end through the loop in the strap.Insert the male end of the connecting strap into the female end of the short strap.Listen for a snapping sound, pull firmly on straps to ensure a good connection.To limit unwanted adjustment, tie an overhand knot with the excess strap directly below the quick-release buckle.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).H3 other text : product was discard.

Event Description

Customer is reporting complaint on product # 2532.(b)(6).Customer is asking if we have any recalls on product # 2532.Customer states they had 2 instances this week with the patient being able to slip their hands freely out of the restraint and pull their intubation tube out and a foley cath.Advise tech services when inspection is completed.

• 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: 17480911
• MDR Text Key: 320600613
• Report Number: 2182318-2023-00070
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 10190676004789
• UDI-Public: 10190676004789
• 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: 07/13/2023

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: 2532
• Device Catalogue Number: 2532
• Device Lot Number: 3094T137
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2023
• 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