MAUDE Adverse Event Report: ASO LLC EQUATE; FLEXIBLE FABRIC BANDAGES ANTIBACTERIAL ALL ONE SIZE

Model Number	UPC#681131228350
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abrasion (1689); Skin Inflammation/ Irritation (4545)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 11/21/2024 retained samples of the same lot as the reported were submitted to the lab for testing 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 10/28/2024, the consumer stated that he had a bad reaction, his skin came off, and he went to the doctor.
Additional Manufacturer Narrative
As of 11/21/2024 retained samples of the same lot as the reported were submitted to the lab for testing 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 01/02/2025 returned samples were submitted to the lab, and no defects were noted.In addition, aso reviewed records of production and 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: b5,b6,d2a,d4, g6, h4, and h6.Udi notes: the expiry date is not present on the device label.
Event or Problem Description
On the initial report received by aso on 10/28/2024, the consumer stated that he had a bad reaction, his skin came off, and he went to the doctor.On the completed cir received from the consumer on 12/05/2024, the consumer stated that he used the bandage on a wasp sting.When the physician evaluated him, she noticed the reddened area where the tape was and told the consumer to stop using the bandage.The consumer stated that the issue was with the tape area.The returned product were.

• Brand Name: EQUATE
• Common Device Name: FLEXIBLE FABRIC BANDAGES ANTIBACTERIAL ALL ONE SIZE
• 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: 20762071
• Report Number: 1038758-2024-00028
• Device Sequence Number: 8587362
• Product Code: KGX
• UDI-Device Identifier: 00681131228350
• UDI-Public: 00681131228350
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/02/2025

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 Model Number: UPC#681131228350
• Device Catalogue Number: 566944586
• Device Lot Number: 00156505
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2021
• 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