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

Model Number UPC#681131112185

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

Patient Problems Abrasion (1689); Skin Irritation (2076)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

As of 03/27/2018 retained product was submitted to the lab for testing in addition to evaluate the biocompatibility studies.While every attempt is made to develop a product that meets all users' needs, there is always a possibility that some consumers may be sensitive to certain adhesives, materials, foods and medicines that can potentially cause irritation to the skin.There was no negative trend identified for the associated product.

Event Description

Consumer submitted a complaint associated with equate extra strength clear nasal strips to fda.Consumer reported that she woke up with a swollen nose after using one strip for the first time overnight.Consumer also reported that the product tore off some of her skin and her nose is red.Fda has requested for the list of ingredients and manufacturer's name and address.

• Brand Name: EQUATE
• Type of Device: EXTRA STRENGTH CLEAR NASAL STRIPS
• 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: 7381473
• MDR Text Key: 103818754
• Report Number: 1038758-2018-00010
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2018

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 Operator: No Information
• Device Expiration Date: 08/04/2022
• Device Model Number: UPC#681131112185
• Device Catalogue Number: 553994071
• Device Lot Number: 00069431
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2018
• Initial Date FDA Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2017
• 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