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

Model Number	UPC#681131436458
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rash (2033)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 10/16/2024 to this date, we have not received unused returned products for further investigation.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 09/19/2024, the consumer reported that the product caused him a rash.The consumer went to the urgent care.
Additional Manufacturer Narrative
As (b)(6) 2024 retained 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.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 reported that the product caused him a rash.The consumer went to the urgent care.On the completed cir received from the consumer on (b)(6) 2024, the consumer stated that he had a rash on his right leg on the bottom.The consumer bought the bandages to use in his rash, and the product caused a rash where the adhesive part was.The consumer confirms that the issue was with the tape.The consumer went to cleveland clinic urgent care.The doctor prescribed prednisone 10mg four times daily for 3 days, and triamcinolone 0.1% cream twice daily.

• Brand Name: EQUATE
• Common Device Name: FLEXIBLE FABRIC ANTIBACTERIAL BANDAGES
• 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
• MDR Report Key: 20474989
• Report Number: 1038758-2024-00027
• Device Sequence Number: 7245689
• Product Code: KGX
• UDI-Device Identifier: 00681131436458
• UDI-Public: 00681131436458
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/14/2024

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#681131436458
• Device Catalogue Number: 598257163
• Device Lot Number: 218516
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2024
• 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