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

Model Number 2530

Device Problem Product Quality Problem (1506)

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

Event Type  malfunction  

Manufacturer Narrative

Customer confirmed the product will not be returning for analysis.Therefore, this event is reported based on the information provided by the customer and from historical data of similar complaints.A review of records found that the most recent material configuration change for the webbing material used in this product was processed in september of 2015.A review of the complaint database did not reveal any similar events against this device.No other complaints regarding the quality of this material have been received.Therefore, it appears this complaint was an isolated event.Instructions for use 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.Application instructions: 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 of the patient¿s reach, using quick-release ties -do not attach to side rail or head/footboard.To increase patient¿s range of motion: place the straps together and attach to a single point along a part of the frame that moves with the patient, out of the patient¿s reach, using quick-release ties.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 report# (b)(4) / manufacturer reference file #(b)(4) product was not returned.

Event Description

Customer states the following: event or problem: health care provider noticed the new type of posey restraints that they get are made of a slippery material.This material has the capability of coming loose after being tied to the bed frame.This issue can cause the patient to pull their lines or accidently extubate themselves.This complaint was filed on product # 2530 with lot# 2172t025.

• Brand Name: FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 2530 lindsay privado drive; unit a; ontario 91761
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 15878561
• MDR Text Key: 307999262
• Report Number: 2182318-2022-00136
• 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: 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: 11/04/2022

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: 2172T025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• 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