MAUDE Adverse Event Report: ASO LLC CVS; NASAL DILATOR DOUBLE BRIDGE TAN

Model Number UPC050428324707

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

Patient Problems Abrasion (1689); Swelling (2091)

Event Date 01/11/2016

Event Type  Injury  

Manufacturer Narrative

Aso was unable to obtain returned samples from consumer.However, aso obtained a lot number and was able to perform testing for adhesion properties on retained samples of the same lot number.In addition, aso reviewed records of biocompatibility tests.

Event Description

Consumer reported that her nose was swelled up from the device and when it took off skin it was very red and in pain.

• Brand Name: CVS
• Type of Device: NASAL DILATOR DOUBLE BRIDGE 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: 5417309
• MDR Text Key: 37700906
• Report Number: 1038758-2016-00011
• 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: 01/11/2016

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 Expiration Date: 09/19/2020
• Device Model Number: UPC050428324707
• Device Catalogue Number: 179331
• Device Lot Number: 36250
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2015
• 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