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

Model Number UPC#681131006729

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 04/21/2022

Event Type  Injury  

Event Description

On the initial report received by aso on 04/21/2022 consumer reported that she developed contact dermatitis under her arm after using the product for 24 hours.She added still have symptoms after 2 weeks.Consumer stated that she is a nurse and that also she consulted with a doctor.She is being treating the site with calamine lotion and triple antibiotic ointment.

Manufacturer Narrative

As of 05/16/2022 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.

• 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: 14431309
• MDR Text Key: 291964571
• Report Number: 1038758-2022-00016
• 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: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UPC#681131006729
• Device Catalogue Number: 566928032
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2022
• 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