MAUDE Adverse Event Report: ASO LLC EQUATE; EXTRA STRENGTH NASAL STRIPS TAN

Model Number UPC# 681131068437

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

Patient Problem Skin Tears (2516)

Event Date 05/12/2022

Event Type  Injury  

Manufacturer Narrative

As of 06/03/2022 retained samples of the same lot as the reported were submitted to the lab for testing with no defects noted.In addition, aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.

Event Description

On the initial report received by aso on 05/04/2022 consumer reported that product ripped her skin off on her nose area.Consumer returned customer information request (cir) on 05/12/2022.Consumer stated that she had an appointment with her dermatologists 2 days later by coincidence.Her dermatologist recommended to keep vaseline on the area and no other treatment recommended.

• Brand Name: EQUATE
• Type of Device: EXTRA STRENGTH NASAL STRIPS TAN
• 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 ; 9413790300
• MDR Report Key: 14657345
• MDR Text Key: 294864392
• Report Number: 1038758-2022-00024
• Device Sequence Number: 1
• Product Code: LWF
• 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: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UPC# 681131068437
• Device Catalogue Number: 552632418
• Device Lot Number: 00160081
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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