MAUDE Adverse Event Report: TIDI PRODUCTS SINGLE PATIENT USE GAIT BELT; AID, TRANSFER

Model Number 6556

Device Problem Device Slipped (1584)

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

Event Type  malfunction  

Event Description

Customer reported via email the canvas on the belt is no longer thick.This is hampering the teeth on the buckle for clamping down firmly.Patient safety is an issue as the belt comes loose easily and could result in a fall.

Manufacturer Narrative

Product is expected to be returned for evaluation but has not been received in by the manufacturer.Therefore this report is based solely on the customer reported issue.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The instructions for use state: during the application of the belt the strap should lay flat across the buckle.Tuck excess under the belt.Always verify proper closure before use.Always check for skin integrity, proper circulation and range of motion when the belt is in use.Ensure that the belt is secure and does not compromise the patient¿s medical condition and does not interfere with tubes, lines or other equipment.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 warnings 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.(b)(4).

• Brand Name: SINGLE PATIENT USE GAIT BELT
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise dr; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise dr; neenah, WI 54956 ; 9207514300
• MDR Report Key: 13874250
• MDR Text Key: 297629420
• Report Number: 2020362-2022-00016
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 02/21/2022

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: 6556
• Device Catalogue Number: 6556
• Device Lot Number: 1300T062
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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