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

Model Number UPC681131068437

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

Patient Problem Abrasion (1689)

Event Date 01/16/2016

Event Type  Injury  

Manufacturer Narrative

Aso lab performed test for adhesion properties on retained samples with the same lot number with no defects found during testing.In addition, aso reviewed records of biocompatibility tests.Refer to section of this report for further details.

Event Description

Consumer reported that the device has been taking the skin off his nose.

• Brand Name: EQUATE
• Type of Device: NASAL DILATOR TRIPLE 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: 5436415
• MDR Text Key: 38208449
• Report Number: 1038758-2016-00016
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/15/2020
• Device Model Number: UPC681131068437
• Device Catalogue Number: 552632418
• Device Lot Number: 35885
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• 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: 59 YR
• Patient Weight: 88