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

Model Number UPC681131068420

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

Patient Problem Abrasion (1689)

Event Date 12/09/2015

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2016 aso has not received response from the consumer.However, aso perform test for adhesion properties on samples retained corresponding to the same lot number.In addition, aso reviewed records of biocompatibility tests performed on materials used to manufactured the same product.If aso receives returned samples we will submit a follow-up report.

Event Description

End user reported that device ripped the skin off her nose.No medical attention was sought.

• Brand Name: EQUATE
• Type of Device: NASAL DILATOR DOUBLE 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: 5354390
• MDR Text Key: 35455071
• Report Number: 1038758-2016-00002
• 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: 12/09/2015

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: 09/26/2020
• Device Model Number: UPC681131068420
• Device Catalogue Number: 552632419
• Device Lot Number: 36744
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2015
• 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: 48 YR