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 04/14/2024

Event Type  Injury  

Event Description

In the initial report received by aso on 04/08/2024, the consumer stated that she had an allergic reaction after using the product.Her back was red where the bandages were, and the consumer said that reaction hurt and looked horrible.On the completed consumer information report (cir) received on 04/18/2024, she states that she went to the dermatologist and was told she had a severe reaction to the bandage.The consumer states that the issue was with the tape area.

Manufacturer Narrative

As of 04/22/2024 returned product and retained 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.

• 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: 19196763
• MDR Text Key: 341202126
• Report Number: 1038758-2024-00008
• 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: 04/26/2024

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: 205584
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2024
• 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