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

Model Number UPC#681131436359

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

Patient Problems Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)

Event Date 05/24/2022

Event Type  Injury  

Event Description

On the initial report received by aso on (b)(6) 2022 consumer reported that product caused an allergic reaction (burning sensation).Consumer stated that she applied the product to protect her nose when using the n95 mask.Consumer went to the hospital because of the burning sensation.

Manufacturer Narrative

As of (b)(6) 2022 retained samples were submitted to the lab for testing, with no defects noted.In addition, aso has reviewed records of biocompatibility tests and latex screening.Refer to relevant tests/laboratory data of this report for further details.

Manufacturer Narrative

As of on (b)(6) 2022, retained samples were submitted to the lab for testing, with no defects noted.In addition, aso has reviewed records of biocompatibility tests and latex screening.Refer to section b.6 of this report for further details.As of 08/05/2022, unused returned product was submitted to the lab for testing, with no defects noted.

Event Description

On the initial report received by aso on 05/24/2022 consumer reported that product caused an allergic reaction (burning sensation).Consumer stated that she applied the product to protect her nose when using the n95 mask.Consumer went to the hospital because of the burning sensation.On completed cir received on 7/11/2022 consumer stated the issue was with the pad area.She added the symptoms corrected after stopped using the product but she still has a mark on her nose.

• 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: 14780753
• MDR Text Key: 295058116
• Report Number: 1038758-2022-00026
• 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,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UPC#681131436359
• Device Lot Number: 00160652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2022
• 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: Female