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	Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
In the initial report received on (b)(6) 2026, the consumer stated that the product left a red mark and caused a burn.According to the completed consumer information report (cir) received on (b)(6) 2026, the consumer clarified that she used the product post-surgery.She reported that the adhesive burned her skin.Consumer returned the product to the store.The consumer returned the product to the store and had the affected area examined by her doctor, who confirmed the reaction appeared to be caused by the adhesive.The consumer stated that the issue was with the tape area and that symptoms resolved after she discontinued using the product.However, she stated that she still has scarring.
Additional Manufacturer Narrative
As of (b)(6) 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.

• 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: 25394868
• Report Number: 1038758-2026-00014
• Device Sequence Number: 10706676
• 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
• Report Date (Section B): 06/04/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 06/04/2026
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female