MAUDE Adverse Event Report: ASO LLC EQUATE; NASAL DILATORS

Model Number UPC 681131068420

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

Patient Problem Abrasion (1689)

Event Date 10/13/2015

Event Type  Injury  

Manufacturer Narrative

Returned samples from the customer were evaluated with no issues detected.Reference section of this report for detailed evaluation.

Event Description

On (b)(6) 2015 the end user alleged that the device caused the skin on her nose to burn and peel.She did not seek medical help.

• Brand Name: EQUATE
• Type of Device: NASAL DILATORS
• 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: 5228496
• MDR Text Key: 31314162
• Report Number: 1038758-2015-00093
• 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: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/11/2020
• Device Model Number: UPC 681131068420
• Device Catalogue Number: 552632419
• Device Lot Number: 00034675
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 68