MAUDE Adverse Event Report: ASO LLC UP&UP; LARGE ADHESIVE PADS

Model Number	UPC#017276226355
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	12/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 01/06/2026, aso was unable to retrieve the lot number information or unused return product.Aso reviewed records of biocompatibility tests, latex screening test with no issues reported.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
In the initial report received on (b)(6) 2025, the consumer stated that when she attempted to remove the bandage, the adhesive caused skin tearing on her abdomen.This resulted in an open wound and scarring.The consumer has been treating the affected area at home and will seek medical attention for potential infection.On the completed consumer information report (cir) received on (b)(6) 2025, the consumer stated that her skin experienced blistering, burning, and tearing.Per the cir, the consumer stated that the issue was with the tape area.The consumer required medical treatment.The doctor at urgent care informed the consumer that the symptoms were consistent with contact dermatitis.The doctor advised the consumer that no other treatment was available at the time.The consumer informed that the area is in the stages of healing and has been applying neosporin and hydrocortisone cream.Consumer informed that symptoms did not correct after she stopped using the product.
Additional Manufacturer Narrative
As of 01/06/2026, aso was unable to retrieve the lot number information or unused return product.Aso reviewed records of biocompatibility tests, latex screening test with no issues reported.Refer to section b6 of this report for further details.As of 1/16/2026, returned/retained product 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.The following sections were updated: b6, d4, g6, h2, h3, h4 and h6.Udi notes: the expiry date is not present on the device label.
Event or Problem Description
In the initial report received on december 12, 2025, the consumer stated that when she attempted to remove the bandage, the adhesive caused skin tearing on her abdomen.This resulted in an open wound and scarring.The consumer has been treating the affected area at home and will seek medical attention for potential infection.On the completed consumer information report (cir) received on december 29, 2025, the consumer stated that her skin experienced blistering, burning, and tearing.Per the cir, the consumer stated that the issue was with the tape area.The consumer required medical treatment.The doctor at urgent care informed the consumer that the symptoms were consistent with contact dermatitis.The doctor advised the consumer that no other treatment was available at the time.The consumer informed that the area is in the stages of healing and has been applying neosporin and hydrocortisone cream.Consumer informed that symptoms did not correct after she stopped using the product.

• Brand Name: UP&UP
• Common Device Name: LARGE ADHESIVE PADS
• 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
• MDR Report Key: 23989435
• Report Number: 1038758-2026-00001
• Device Sequence Number: 16084843
• Product Code: KGX
• UDI-Device Identifier: 00017276226355
• UDI-Public: 00017276226355
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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#017276226355
• Device Catalogue Number: ITEM #245-07-0726
• Device Lot Number: 248949
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2025
• 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