MAUDE Adverse Event Report: ASO LLC EQUATE; NASAL DILATOR

Model Number UPC681131068437

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Skin Tears (2516)

Event Date 11/04/2015

Event Type  Injury  

Manufacturer Narrative

Aso evaluated retained samples for adhesion properties on 11/19/2015 with no issues observed with the samples.In addition, aso evaluated returned samples by the end user for adhesion properties on 11/16/2015 with no issues observed with the samples.Also reviewed satisfactory biocompatibility reports on products manufactured with the same materials.

Event Description

On (b)(6) 2015 - end user / patient claims the device was ineffective and ripped the skin off her nose.End user / patient did not seek medical attention.

• Brand Name: EQUATE
• Type of Device: NASAL DILATOR
• 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: 5266883
• MDR Text Key: 32668421
• Report Number: 1038758-2015-00107
• 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: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• 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
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 71