MAUDE Adverse Event Report: ASO LLC EQUATE; NASAL DILATOR

Catalog Number 552632418

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

Patient Problem Abrasion (1689)

Event Date 04/28/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 - the end user claimed the device has torn off the left side of her nose.

• Brand Name: EQUATE
• Type of Device: NASAL DILATOR
• Manufacturer (Section D): ASO LLC; sarasota FL 34240
• Manufacturer Contact: 300 sarasota center blvd.; sarasota, FL 34240 ; 9413790300
• MDR Report Key: 4833664
• MDR Text Key: 5905796
• Report Number: 1038758-2015-00029
• 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: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/22/2020
• Device Catalogue Number: 552632418
• Device Lot Number: 00024833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR