MAUDE Adverse Event Report: ASO LLC CVS HEALTH; EXTRA STRENGTH NASAL STRIPS

Model Number UPC#050428251348

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

Patient Problem Bruise/Contusion (1754)

Event Date 02/14/2018

Event Type  Injury  

Manufacturer Narrative

As of 03/12/2018 unused return product and retained samples were 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

Customer stated that the product caused blue/black scar on his nose.

• Brand Name: CVS HEALTH
• Type of Device: EXTRA STRENGTH 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: 7343431
• MDR Text Key: 102569431
• Report Number: 1038758-2018-00008
• 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: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/28/2020
• Device Model Number: UPC#050428251348
• Device Catalogue Number: 542630
• Device Lot Number: 00037717
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1