MAUDE Adverse Event Report: TIDI PRODUCTS LLC AQUAGUARD MOISTURE BARRIER CLEAR POLYETHYLENE; TAPE AND BANDAGE, ADHESIVE

Model Number 50011-RPK

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

H3: the product is scheduled to be returned but has not been received by manufacturer at the time of this report.Therefore, this report is based solely on the information provided by the customer.The device history record for this lot was reviewed and identified no nonconformances or other issues noted that could have contributed to the reported issue.All inspected samples passed prior to release of the lot for distribution.The instructions for use were reviewed and appear to be adequate for use of this product.Aquaguard is intended for showering only and is not recommended for submersion under water.Aquaguard is not a replacement for primary dressings.For best results, a caregiver should apply the aquaguard product to the patient.Apply aquaguard to clean dry skin.Do not use lotion or cream before applying.Do not lift and/or attempt to reposition aquaguard after placement.Do not use if punctured or showing signs of wear.Aquaguard is a single use product.If reused, it may not provide an effective barrier while showering.If sensitivity or irritation develops discontinue use.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.Manufacturer reference file (b)(4).

Event Description

On (b)(6) 2023, (b)(6) contacted tidi via phone.She advised that she purchased 50011-rpk.She stated that the aquaguard failed to work properly.Customer wounds got wet and did not protect.

• Brand Name: AQUAGUARD MOISTURE BARRIER CLEAR POLYETHYLENE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah IL 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, IL 54956
• MDR Report Key: 16872459
• MDR Text Key: 314643758
• Report Number: 2182318-2023-00033
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2023

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: 50011-RPK
• Device Catalogue Number: 50011-RPK
• Device Lot Number: 54775241
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2022
• 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