MAUDE Adverse Event Report: ASO PHILIPPINES UP&UP; FLEXIBLE XL FABRIC BANDAGES

Model Number	UPC#017276226256
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On the initial report received by aso on (b)(6) 2026, the consumer stated that the product caused her irritation under the arm and on the left side of the breast.The incident did not result in hospitalization, but the consumer sought primary care medical attention on (b)(6) 2026.
Additional Manufacturer Narrative
As (b)(6) 2026 aso was unable to retrieve the lot number information or unused return product.Aso reviewed records of biocompatibility tests and latex screening with no issues reported.Refer to section b.6 of this report for further details.

• Brand Name: UP&UP
• Common Device Name: FLEXIBLE XL FABRIC BANDAGES
• Manufacturer (Section D): ASO PHILIPPINES; 4th st block d-5, mez 1; lapulapu city, cebu ; RP
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd; sarasota FL 34240
• Manufacturer Contact: aso complaints ; 300 sarasota center blvd.; 9413790300
• MDR Report Key: 25015173
• Report Number: 1038758-2026-00010
• Device Sequence Number: 15838347
• Product Code: KGX
• UDI-Device Identifier: 00017276226256
• UDI-Public: 00017276226256
• 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): 04/28/2026

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#017276226256
• Device Catalogue Number: 245-07-0727
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/28/2026
• 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