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

Model Number UPC#041260370755

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

Patient Problem Abrasion (1689)

Event Date 01/18/2018

Event Type  Injury  

Manufacturer Narrative

As of 02/13/2018 aso evaluated returned samples as well as retained samples of the same lot number for adhesion properties.In addition, aso reviewed records of biocompatibility tests.

Event Description

Consumer stated that product took a portion of her skin off.

• Brand Name: KROGER
• 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: 7269320
• MDR Text Key: 99993086
• Report Number: 1038758-2018-00003
• 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: 01/18/2018

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: No Information
• Device Expiration Date: 10/13/2022
• Device Model Number: UPC#041260370755
• Device Lot Number: 00073981
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2017
• 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