MAUDE Adverse Event Report: ASO LLC EQUATE; NASAL DILATOR

Catalog Number 551594655

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

Patient Problems Abrasion (1689); Skin Irritation (2076)

Event Date 04/02/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 - the consumer alleged the nasal dilator caused an allergic reaction.Her face is red and so is her nose, it does not sting or hurt, it is just red.

• Brand Name: EQUATE
• Type of Device: NASAL DILATOR
• Manufacturer (Section D): ASO LLC; sarasota FL
• Manufacturer Contact: 300 sarasota center blvd.; sarasota, FL 34240
• MDR Report Key: 4817872
• MDR Text Key: 5929893
• Report Number: 1038758-2015-00019
• 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: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/04/2020
• Device Catalogue Number: 551594655
• Device Lot Number: 20386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2015
• 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: 71 YR
• Patient Weight: 104