MAUDE Adverse Event Report: ASO, LLC EQUATE; NASAL DILATOR

Catalog Number 551594655

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

Patient Problem Abrasion (1689)

Event Date 05/15/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 - the end user is claiming that the device caused her to have sore skin on her nose and to have some bleeding out of her right nostril.No medical attention sought.

• Brand Name: EQUATE
• 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: 4861456
• MDR Text Key: 5812264
• Report Number: 1038758-2015-00036
• 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: 06/18/2015

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
• Device Lot Number: 28383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2015
• Initial Date FDA Received: 06/19/2015
• 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
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 61