MAUDE Adverse Event Report: TIDI PRODUCTS, LLC TIDI PRODUCTS, LLC GRIP-LOK; FOLEY SECUREMENT DEVICE WITH ADHESIVE

Model Number 3400LFC

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Skin Tears (2516)

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product was not returned for evaluation.This report is based on the information provided by the customer.Further information regarding the use of this device is not available for analysis.No anomalies or nonconformances were noted in the device history record of this lot which could have contributed to this event.Historical complaint data was reviewed and found one other similar complaint for this part.This complaint was received over 2 years ago for the complaint of device not sticking; subsequently pulling, causing pain and slight bleeding.The normalize rate of this type of complaint is (b)(4) for these products.The customer's note that, "moisture decreases life expectancy" suggests that the device instructions for use may not have been followed completely.As a precaution, refresher in-service training has been performed with the staff, with the focus around proper skin prep and placement in effort to prevent these issues from occurring again.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use (ifu) 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 at present.All complaints are trended and reviewed by management on a monthly cadence.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented, and acted upon as appropriate.(b)(4).

Event Description

Over the past little while some patients experiencing tears to the urethral.Staff finding product not sticking to the leg and/or not staying long.Moisture decreases life expectancy.A second device was required.

• Brand Name: TIDI PRODUCTS, LLC GRIP-LOK
• Type of Device: FOLEY SECUREMENT DEVICE WITH ADHESIVE
• Manufacturer (Section D): TIDI PRODUCTS, LLC; 570 enterprise drive; neenah WI 54956
• MDR Report Key: 12602467
• MDR Text Key: 281108123
• Report Number: 2182318-2021-00011
• Device Sequence Number: 1
• Product Code: KMK
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 3400LFC
• Device Catalogue Number: 3400LFC
• Device Lot Number: 45258376
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1