MAUDE Adverse Event Report: ASO LLC CVS; NASAL DILATOR 4 TOUCH CLEAR

Model Number UPC050428470817

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

Patient Problem Abrasion (1689)

Event Date 01/12/2016

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2016 aso has not received returned samples from consumer.Consumer does not have box with lot number available.Aso reviewed biocompatibility test records.Please refer to report for further details.No lot number or returned samples.

Event Description

Consumer reported that device ripped the skin off the bridge of his nose.Nose is ok but is red.

Manufacturer Narrative

Aso received returned samples of the device on 03/02/2016.Device was evaluated for adhesion properties on 03/04/2016.Results of test are acceptable with no defects found during testing.No lot number was provided by consumer so aso is unable to perform further investigation.

• Brand Name: CVS
• Type of Device: NASAL DILATOR 4 TOUCH CLEAR
• 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: 5417604
• MDR Text Key: 37713737
• Report Number: 1038758-2016-00013
• 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,Followup
• Report Date: 01/12/2016

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 Model Number: UPC050428470817
• Device Catalogue Number: 949528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1