MAUDE Adverse Event Report: ASO LLC EQUATE; EXTRA STRENGTH NASAL STRIPS

Model Number UPC#681131112185

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

Patient Problem Irritation (1941)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2019 retained samples were submitted to the lab for testing in addition to review records of biocompatibility tests.Unable to confirm the customer's specific issue due to the verbiage provided, the customer could not be contacted.

Event Description

The report received from the reporting agency noted the following: " patient claims the nasal strip is causing her to spread wide" and medical attention will be sought.

• Brand Name: EQUATE
• Type of Device: EXTRA STRENGTH NASAL STRIPS
• 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
• MDR Report Key: 8379449
• MDR Text Key: 137451680
• Report Number: 1038758-2019-00007
• 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: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/05/2023
• Device Model Number: UPC#681131112185
• Device Catalogue Number: 553994071
• Device Lot Number: 00097395
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2018
• 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 Outcome(s): Other