MAUDE Adverse Event Report: ASO LLC CVS HEALTH; NASAL STRIPS CLEAR MEDIUM

Model Number UPC#050428270752

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

Patient Problems Skin Irritation (2076); Skin Tears (2516)

Event Date 07/17/2017

Event Type  Injury  

Manufacturer Narrative

As of 09/18/2017 the initial complaint by the customer did not indicate that an mdr would be required.However, the consumer stated on 08/22/2017 that he required treatment.Based on the information received, aso opted to file an mdr.Aso has reviewed records of biocompatibility tests.

Event Description

The initial report on 07/18/2017, the customer stated that product irritated his nose, ripped his skin off and left it red and sore the next day.However, on 08/22/2017 the consumer sent a follow up report indicating that he required treatment.

• Brand Name: CVS HEALTH
• Type of Device: NASAL STRIPS CLEAR MEDIUM
• 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: 6893242
• MDR Text Key: 87352146
• Report Number: 1038758-2017-00031
• 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: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC#050428270752
• Device Catalogue Number: 953437
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2017
• 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