MAUDE Adverse Event Report: ASO LLC EQUATE; NASAL DILATOR TRIPLE BRIDGE CLEAR

Model Number UPC681131112185

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

Patient Problem Abrasion (1689)

Event Date 01/18/2016

Event Type  Injury  

Manufacturer Narrative

Aso has conducted test for adhesion properties on samples returned by consumer as well as retained samples of the same lot number with no defects found during testing.In addition, aso has reviewed records of biocompatibility tests performed on materials used to manufacture the same type of product.Please refer to section of this report for further details.

Event Description

Consumer reported that device ripped the skin off his nose and the device did not work.Device came off on left side and skin was torn off.

• Brand Name: EQUATE
• Type of Device: NASAL DILATOR TRIPLE BRIDGE 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: 5436374
• MDR Text Key: 38208075
• Report Number: 1038758-2016-00015
• 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: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/04/2020
• Device Model Number: UPC681131112185
• Device Catalogue Number: 553994071
• Device Lot Number: 39932
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2015
• 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
• Patient Age: 43 YR
• Patient Weight: 127