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

Model Number 6556L

Device Problem Device Slipped (1584)

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

Event Type  malfunction  

Manufacturer Narrative

Summary evaluation: product has been received but evaluation of the device was not completed at the time of this report.Historical review of similar cases found that the webbing exhibited slippage or the buckle teeth was not securing the webbing if the webbing was not slipped through the buckle all the way.Using the ifu application, the webbing did not exhibit any slippage.There were several complaints received for straps slipping which were determined to be due to manufacturing issues that have been addressed via the capa system.A review of the device history record did not show any nonconformities and the device passed all product verification testing and met specifications when shipped 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.All complaints are trended and reviewed by management on a monthly basis.As a part of the monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Manufacturer reference file (b)(4).

Event Description

Customer contacted us via email.The customer is returning product because it is part of lot # 1341t342 with the thinner strap material.This is a known issue and the product is being swapped on 1 for 1 basis.

• Brand Name: SINGLE PATIENT GAIT BELT LONG
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise drive; neenah WI
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 15491573
• MDR Text Key: 306360520
• Report Number: 2182318-2022-00111
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 6556L
• Device Catalogue Number: 6556L
• Device Lot Number: 1341T342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/08/2021
• 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