MAUDE Adverse Event Report: ASO LLC TOPCARE HEALTH; STERILE ANTIBACTERIAL WATERPROOF STRONG STRIPS BANDAGES, ALL ONE SIZE

Model Number	UPC#036800403086
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of (b)(6) 2025 retained samples were submitted to the lab with no defects noted.In addition, aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.Refer to section b.6 of this report for further details.Udi notes: the expiry date is not present on the device label.
Event or Problem Description
On the initial report received on (b)(6) 2025, the consumer stated that she had a biopsy and used the waterproof strong strip bandages to protect the wound.However, she stated that water entered the wound while she was in a hot tub, raising concerns for an infection.On a follow-up message received on (b)(6) 2025, the consumer stated that the incision had become red and was spreading.On (b)(6) 2025, she contacted aso stating that she had an appointment scheduled with her doctor regarding her incision.However, she was planning to see the doctor sooner because her incision had now become red and the redness was spreading.On the completed consumer information report (cir) received on (b)(6) 2025, the consumer specified that water entered the wound around the short sides of the tape area.She confirmed that the skin became red and she required dermatologist treatment.The consumer stated that the issue was with the short sides of the tape area and that the symptoms did not resolve after she stopped using the product.
Additional Manufacturer Narrative
As of 11/14/2025, retained samples were submitted to the lab with no defects noted.In addition, aso 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.As of 12/01/2025, unused returned product was submitted to the lab for testing with no defects noted.In addition, aso reviewed records of biocompatibility tests with no issues noted.Refer to section b.6 of this report for further details.The following sections were updated: b6, g2, g6, h2, and h6.Udi notes: the expiry date is not present on the device label.
Event or Problem Description
On the initial report received on october 21, 2025, the consumer stated that she had a biopsy and used the waterproof strong strip bandages to protect the wound.However, she stated that water entered the wound while she was in a hot tub, raising concerns for an infection.On a follow-up message received on october 23, 2025, the consumer stated that the incision had become red and was spreading.On october 24, 2025, she contacted aso stating that she had an appointment scheduled with her doctor regarding her incision.However, she was planning to see the doctor sooner because her incision had now become red and the redness was spreading.On the completed consumer information report (cir) received on november 11, 2025, the consumer specified that water entered the wound around the short sides of the tape area.She confirmed that the skin became red and she required dermatologist treatment.The consumer stated that the issue was with the short sides of the tape area and that the symptoms did not resolve after she stopped using the product.

• Brand Name: TOPCARE HEALTH
• Common Device Name: STERILE ANTIBACTERIAL WATERPROOF STRONG STRIPS BANDAGES, ALL ONE SIZE
• 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.; sarasota, FL 34240 ; 9413790300
• MDR Report Key: 23584885
• Report Number: 1038758-2025-00029
• Device Sequence Number: 21137959
• Product Code: KGX
• UDI-Device Identifier: 00036800403086
• UDI-Public: 00036800403086
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 12/16/2025

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#036800403086
• Device Lot Number: 239911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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 Sex: Female