MAUDE Adverse Event Report: ASO PHILIPPINES UO&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	09/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On the initial report received by aso on 09/09/2024, the consumer stated that he sought medical attention.He was prescribed a steroid to soothe the swelling.
Additional Manufacturer Narrative
As of 07/31/2024, no returned products were provided.Unused retained samples of the same lot as the reported 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.
Additional Manufacturer Narrative
As 09/30/2024, returned 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.Udi notes: the expiry date is not present on the device label.
Event or Problem Description
On the initial report received by aso on 09/09/2024, the consumer stated that he sought medical attention.He was prescribed a steroid to soothe the swelling.On the completed cir received from the consumer on 09/03/2024, the consumer states that the product caused a dermic allergic reaction.The consumer states that he wore the bandage for one day and noticed slight irritation under it.The consumer replaced the target bandage with a walmart bandage and changed it daily.The wound healed after a couple of days of wearing the walmart bandage.He peeled off the bandage once the cut was fully healed and discovered a perfect rectangle of the allergic reaction with red swelling bumps.Per cir, the consumer had two telehealth sessions and was prescribed triamcinolone acetonide cream usp 0.1%, a topical steroid.The steroid successfully stopped the swelling on his skin.The reaction left a dark rectangle that partly disappeared over the last month.

• Brand Name: UO&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: 19887521
• Report Number: 1038758-2024-00017
• Device Sequence Number: 20777965
• Product Code: KGX
• UDI-Device Identifier: 00017276226256
• UDI-Public: 00017276226256
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 09/30/2024

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 Lot Number: 210402
• 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: 07/09/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• 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: Male