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

Model Number UPC#681131006729

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 03/26/2024

Event Type  Injury  

Manufacturer Narrative

As of 04/01/2024 aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.In addition, complaint database was reviewed and no negative trend has been identified for the associated product.Refer to section b.6 of this report for further details.

Event Description

On the initial report received by aso on 02/28/2024, the consumer states that she had an allergic reaction after using the product.On the completed consumer information report (cir) received on 03/26/2024, she states that she went to the dermatologist and was recommended to use cool towels, tefa bandages, and paper tape to keep cover her original wound.The cool towels were recommended for the bandage burn itself.The consumer states that the issue was with the tape area.

• Brand Name: EQUATE
• Type of Device: FLEXIBLE FABRIC BANDAGES ANTIBACTERIAL ALL ONE SIZE
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd; sarasota 34240
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd; sarasota FL 34240
• Manufacturer Contact: aso complaints ; 300 sarasota center blvd.; 9413790300
• MDR Report Key: 19055433
• MDR Text Key: 339548086
• Report Number: 1038758-2024-00007
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2024

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#681131006729
• Device Lot Number: 00204140
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female