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

Model Number UPC050428079829

Device Problem Failure to Obtain Sample (2533)

Patient Problem Bruise/Contusion (1754)

Event Date 01/22/2016

Event Type  Injury  

Manufacturer Narrative

As of 02/19/2016 aso has not received information from the consumer regarding a lot number or returned samples of the same lot.Aso was unable to conduct test for adhesion properties on the product.However, aso reviewed records of biocompatibility tests for materials used to manufacture the same type of products.Device evaluated by mfr: consumer has not provided information.

Event Description

Consumer reported that shortly after using the device, her nose started hurting and when she took it off, her nose was bruised.Consumer will be seeking medical attention.

• Brand Name: CVS
• Type of Device: NASAL DILATOR TAN LARGE
• 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: 5448776
• MDR Text Key: 38631328
• Report Number: 1038758-2016-00022
• 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: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC050428079829
• Device Catalogue Number: 322840
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1