MAUDE Adverse Event Report: ASO LLC EQUATE NASAL DILATORS CLEAR 4-TOUCH 26CT.

Catalog Number 551594655

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Abrasion (1689)

Event Date 06/26/2015

Event Type  Injury  

Event Description

On 06/26/2015, the end user alleged that the device took the skin off of her nose.

Manufacturer Narrative

On 07/27/2015 - testing of returned product in process.

• Brand Name: EQUATE NASAL DILATORS CLEAR 4-TOUCH 26CT.
• Type of Device: NASAL DILATOR
• Manufacturer (Section D): ASO LLC; sarasota FL
• Manufacturer Contact: 300 sarasota center blvd.; sarasota, FL 34240 ; 9413790300
• MDR Report Key: 4948753
• MDR Text Key: 6033745
• Report Number: 1038758-2015-00055
• 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,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 07/27/2015

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: Lay User/Patient
• Device Catalogue Number: 551594655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 07/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2015
• 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