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

Model Number UPC#681131006729

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

Patient Problem Skin Burning Sensation (4540)

Event Date 09/20/2022

Event Type  Injury  

Manufacturer Narrative

As of 10/11/2022 aso submitted unused returned product and retained samples for testing with no defects observed.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 this report for further details.

Event Description

Consumer stated on (b)(6) 2022 that product caused a burn.Consumer returned customer information request (cir) on (b)(6) 2022.Consumer informed that the product left a chemical burn and the issue was with the tape area.Consumer stated that he required medical attention and that the symptoms corrected after he stopped using the product.

• Brand Name: EQUATE
• Type of Device: FLEXIBLE FABRIC BANDAGES ANTIBACTERIAL
• 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, FL 34240
• MDR Report Key: 15609631
• MDR Text Key: 301821057
• Report Number: 1038758-2022-00042
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UPC#681131006729
• Device Lot Number: 00166929
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• 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: Male