MAUDE Adverse Event Report: TIDI PRODUCTS LLC AQUAGUARD; TAPE AND BANDAGE, ADHESIVE

Device Problems Leak/Splash (1354); Product Quality Problem (1506)

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

Event Type  malfunction  

Manufacturer Narrative

This information was obtained from an amazon review.The device is unavailable for evaluation, no further information is available at this time.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 underwater.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.Complaint reference: (b)(4).

Event Description

This is an amazon review dated oct.22, 2021 for a10"x12",bg50011rpkpk - aqua guard moisture barrier, 10 x 12 retail pack.Description: falls off when wet, this product is worthless.I ordered it to cover a surgery so i could shower.When it got wet, the adhesive failed in many areas allowing water into the surgery site.Again, this is an amazon review subsequently additional information is unavailable at this time.

• Brand Name: AQUAGUARD
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): TIDI PRODUCTS LLC; tidi products llc; 570 enterprise dr; neenah 54956
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 13541457
• MDR Text Key: 288482158
• Report Number: 2020362-2022-00005
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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