MAUDE Adverse Event Report: ASO LLC EQUATE; WATERSHIELD PLUS ANTIBACTERIAL ADHESIVE BANDAGES

Model Number	UPC#681131349826
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report received by the fda on january 12, 2026, a consumer filed a voluntary mdr (report #mw5180820).The consumer stated that she used the product to cover a spot on her son's face to prevent infection.The following day, the daycare sent a photograph showing that the skin where the bandage had been applied was "bubbled up." the consumer stated that the bandage caused a chemical burn.On the completed consumer information request form (cir) received on february 06, 2026, the consumer states that her son had a blemish on face and she used the bandage to cover it.A day later, his face was bubbled/blistered.The patient was evaluated by a pediatrician, who prescribed an antibiotic and a steroid ointment.The consumer specified the reaction occurred in the area of the adhesive tape.While the consumer confirmed that symptoms improved after discontinuing product use, she noted that the area is not yet fully healed.
Additional Manufacturer Narrative
As of 03/03/2026 aso performed testing with retained samples and reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.Refer to section b6 of this report for further details.

• Brand Name: EQUATE
• Common Device Name: WATERSHIELD PLUS ANTIBACTERIAL ADHESIVE BANDAGES
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd; sarasota FL 34240
• Manufacturer Contact: aso complaints ; 300 sarasota center blvd.
• MDR Report Key: 24519925
• Report Number: 1038758-2026-00007
• Device Sequence Number: 20963036
• Product Code: KGX
• UDI-Device Identifier: 00681131349826
• UDI-Public: 00681131349826
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K983368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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 Model Number: UPC#681131349826
• Device Catalogue Number: 579329705
• Device Lot Number: 244919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2025
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 MO
• Patient Sex: Male
• Patient Weight: 17 KG