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

Model Number	50015-RPK
Medical Device Problem Code	Moisture Damage (1405)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product is not available for return or evaluation.Therefore, this event is reported solely on the information provided by the customer.A review of the complaint database revealed similar events against issues reported with adhesive issue.Majority of these complaints are from amazon feedback and product is not returned, therefore, root cause could not be determined.Possible root cause is user error, as there is evidence that the customer is not using the correct device based on the location for application.The correct device was suggested to the customer as a replacement.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.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, trends and excursions above control limits will be assessed, documented and acted upon as warranted.No corrective or preventative actions are necessary at this time.Manufacturer reference file # (b)(4).
Event or Problem Description
Again i have to unfortunately use your product again and this is the result from it.I now have to get the ir team to come stick me again which is just a great time and all because of your poor quality product.What are you people thinking over there?? how do you people even stay in business and why is there no competition to you?.

• Brand Name: AG-SB, 9X9, RETAIL PKG
• Common Device Name: 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: 21020400
• Report Number: 2182318-2024-00172
• Device Sequence Number: 4070925
• Product Code: KGX
• UDI-Device Identifier: 00618125190294
• UDI-Public: 00618125190294
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2024

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-RPK
• Device Catalogue Number: 50015-RPK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown