MAUDE Adverse Event Report: ASO LLC EQUATE; NASAL DILATOR CLEAR 4 TOUCH

Model Number UPC681131062749

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

Patient Problem Abrasion (1689)

Event Date 01/14/2016

Event Type  Injury  

Manufacturer Narrative

Aso has reviewed records of testing for adhesion properties on retain samples as well as records of acceptable biocompatibility tests.

Event Description

Consumer reported that the device pulled skin off his nose.

Manufacturer Narrative

This follow-up is to address a correction, patient identifier originally reported as (b)(4), however, the correct patient identifier is (b)(6).

• Brand Name: EQUATE
• Type of Device: NASAL DILATOR CLEAR 4 TOUCH
• 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: 5434823
• MDR Text Key: 38171115
• Report Number: 1038758-2016-00014
• 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,Followup
• Report Date: 01/14/2016

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: 03/21/2019
• Device Model Number: UPC681131062749
• Device Catalogue Number: 551594655
• Device Lot Number: 10770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 02/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2014
• 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: 78 YR
• Patient Weight: 68