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

Model Number UPC681131068437

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

Patient Problem Abrasion (1689)

Event Date 12/15/2015

Event Type  Injury  

Manufacturer Narrative

Aso has reviewed records from previous reports for this product and lot number and there has been one more report on the same lot number.Aso will continue to monitor the product complaints to identify possible trends.Aso has reviewed records of testing for adhesion properties on retain samples as well as records of biocompatibility tests.Refer to section of this report for details.

Event Description

Consumer reported that when removing device this tore the skin off of the bridge of his nose.No medical attention was sought.

• Brand Name: EQUATE
• Type of Device: NASAL DILATOR EXTRA STRENGTH 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: 5359734
• MDR Text Key: 35619606
• Report Number: 1038758-2016-00003
• 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: 12/16/2015

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: 09/25/2020
• Device Model Number: UPC681131068437
• Device Catalogue Number: 552632418
• Device Lot Number: 36560
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2015
• 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: 69 YR
• Patient Weight: 87