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

Model Number 2532

Device Problem Material Disintegration (1177)

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

Event Type  malfunction  

Manufacturer Narrative

H3 device was discarded and is not available for return or evaluation.Therefore, this report is based solely on the information provided by the customer.A picture of the reported product was provided by the customer.The restraint is shredding and the foam material of the product appeared to be soiled as the color of the restraint was darker blue in some areas and lighter in others.The customer noted the patient was a large male that was sweating while product was in use.Possible causes: 1.) patient is combative or aggressive, 2.) patient was assessed incorrectly when choosing the appropriate wrist restraint leading to the incorrect restraint applied, 3.) patient was cooperative in the beginning, but became emotional or felt discomfort with the restraints and became aggressive or combative, 4.) soiled product with excessive pulling caused restraint to shred.A review of the complaint database did not reveal any similar events against this issue in the past two years.Therefore, it appears this complaint was an isolated event.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Per the ifu: 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.Additionally, the ifu warns: 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.Without return of the device the reported issue could not be confirmed.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.Therefore, no further 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 mdr report #: mw5117621 / manufacturer reference file (b)(4).H3 other text : product not returned.

Event Description

Customer is reporting a complaint on product 2532.(b)(6).Customer has filed a fda complaint stating that the 2532 shredded and broke apart due to a patient pulling, and fragments were present on the patient skin and bed linens.Mdr# mw5117621 for fda report.

• 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: 17240858
• MDR Text Key: 318342752
• Report Number: 2182318-2023-00056
• 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: 05/31/2023

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: 4020T56
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2014
• 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
• Patient Sex: Male
• Patient Weight: 121 KG