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

Model Number UPC#681131006712

Device Problems Failure to Obtain Sample (2533); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burning Sensation (2146); Skin Inflammation/ Irritation (4545)

Event Date 03/29/2022

Event Type  Injury  

Manufacturer Narrative

As of 04/22/2022 aso has no received returned samples from consumer or lot info.However, aso reviewed records of biocompatibility tests and latex screening with no issues noted.

Event Description

On the initial report received by aso on 03/29/2022 consumer reported that her child had a chemical burn after using the product.Consumer stated that her daughter sought medical attention.She was treated with antibiotics and burn cream.In addition, consumer stated that product caused blisters.

• 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: federico juliao ; 300 sarasota center blvd.; sarasota, FL 34240
• MDR Report Key: 14208650
• MDR Text Key: 290075751
• Report Number: 1038758-2022-00012
• 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: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UPC#681131006712
• Device Catalogue Number: 566928030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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