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

Model Number 2532

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

H3: this report is based solely on the information provided by the customer.Upon due diligence, (b)(6), confirmed that the device would not be returned for analysis.Additionally, she confirmed that the facility was educated on application of the device and new protocols and buckle needs were implemented.Historical data found complaints of unintentional patient release for the foam limb holder part 2532.Of those returned, broken clips, excessive force, and/or wear and tear has contributed to the malfunction.Other similar complaints were determined to be due to improper application of the device or use with incorrect patient population per the product ifu.A device history record (dhr) of the affected lot number did not reveal any issues.No ncrs were identified.The unit passed all verification testing and met manufacturing specifications prior to being released 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.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.Manufacturer reference file (b)(4).H3 other text : product not returned.

Event Description

Customer is reporting a complaint on product # 2532.(b)(6).Customer states that the customer is having a problem with the product.Detail were not provided and information is limited to the above.Advise tech services when inspection has been 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: 17686324
• MDR Text Key: 322716489
• Report Number: 2182318-2023-00080
• 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: 08/08/2023

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: 3174T038
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2023
• 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