MAUDE Adverse Event Report: TIDI PRODUCTS LLC AG-SB, 9X9, PACKAGE; TAPE AND BANDAGE, ADHESIVE

Model Number 50015-PKG

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

This information was obtained from an amazon review.The device is unavailable for evaluation and information is limited to that which was contained within the review.Aquaguard is a one use, non-sterile product.The complaint rate over the past two years including amazon review feedback is 0.009%, with no medical interventions or serious incidents reported to date.There have been no incidents or evidence to suggest if a wound or surgical site were to become wet from a shower that a serious incident, infection, medical intervention, or death would occur.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.Please reference instructions for use (ifu) or ifu video for application details.If reused, it may not provide an effective barrier while showering.Reference: (b)(4).

Event Description

Amazon review (b)(6) 2022.: not waterproof: bought this for my mom so she can shower with a tube coming out of her back/kidney.At first, my dad was thrilled that the center didn't have adhesive so it wouldn't stick to her bandage but he just gave me an update and the whole thing failed miserably.Her entire dressing is soaked and now has to be replaced due to infection risk.

• Brand Name: AG-SB, 9X9, PACKAGE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 14651385
• MDR Text Key: 298245873
• Report Number: 2182318-2022-00072
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2022

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: 50015-PKG
• Device Catalogue Number: 50015-PKG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2022
• Initial Date FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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