MAUDE Adverse Event Report: ASO LLC MEMBER'S MARK; EXTRA STRENGTH NASAL STRIPS

Model Number UPC#078742094656

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

Patient Problem Pain (1994)

Event Date 11/03/2017

Event Type  Injury  

Manufacturer Narrative

As of 12/01/2017 consumer did not return unused samples for further investigation.Aso reviewed records of biocompatibility tests, latex screening on adhesive and adhesion properties on samples associated with the product.Refer to section for further details.

Event Description

Consumer reported that product caused him serious under eye pain.

• Brand Name: MEMBER'S MARK
• 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: 7076102
• MDR Text Key: 93501742
• Report Number: 1038758-2017-00046
• 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: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC#078742094656
• Device Catalogue Number: 614388119
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1