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

Model Number UPC#681131006729

Device Problem Off-Label Use (1494)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/08/2022

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2022 unused returned samples were submitted to the lab for testing with no defects noted.In addition, aso reviewed records of biocompatibility tests and latex screening.This report for further details.Consumer stated that used the product on her eye.The product package label states "do not use in the eyes".

Event Description

On the initial report received by aso on 04/08/2022 consumer reported that product caused a reaction and medical treatment was sought.Consumer stated that the product was used on her eyes causing an allergic reaction.We received completed customer information request (cir) from the consumer on 04/27/2022.Consumer stated that the issue was with the tape area and that the symptoms corrected after she stopped using the product.Her doctor prescribed cephalexin.

• 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: 14304179
• MDR Text Key: 294660423
• Report Number: 1038758-2022-00013
• 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: 05/04/2022

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: 00158991
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2021
• 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