MAUDE Adverse Event Report: ASO LLC SIGNATURE CARE; EXTRA LARGE STRONG STRIPS ADHESIVE BANDAGES ONE SIDE

Model Number	UPC#321130795674
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of (b)(6)2024 returned product 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 (b)(6)2024, the consumer stated that she had a sore on her leg and applied the product for approximately eight hours.When she removed the product, it tore the top layer of her skin.On the completed consumer information report (cir) received on (b)(6)2024, the consumer states that the wound became infected.Three doctors treated the wound, which is starting to heal now.The consumer states that the issue was with the tape.
Additional Manufacturer Narrative
As of 12/02/2024, eturned product 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.As of 01/02/2025, retained samples were evaluated by the manufacturer with no issues found.Udi notes: the expiry date is not present on the device label.
Event or Problem Description
On the initial report received by aso on 09/17/2024, the consumer stated that she had a sore on her leg and applied the product for approximately eight hours.When she removed the product, it tore the top layer of her skin.On the completed consumer information report (cir) received on 11/05/2024, the consumer states that the wound became infected.Doctors treated the wound, which is starting to heal now.The consumer states that the issue was with the tape.

• Brand Name: SIGNATURE CARE
• Common Device Name: EXTRA LARGE STRONG STRIPS ADHESIVE BANDAGES ONE SIDE
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd; sarasota FL
• Manufacturer Contact: 300 sarasota center blvd.
• MDR Report Key: 20825212
• Report Number: 1038758-2024-00029
• Device Sequence Number: 8928352
• Product Code: KGX
• UDI-Device Identifier: 00321130795674
• UDI-Public: 00321130795674
• Combination Product (Y/N): N
• 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): 01/06/2025

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 Expiration Date: 04/05/2025
• Device Model Number: UPC#321130795674
• Device Catalogue Number: 321130795674
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2020
• 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