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 Skin Irritation (2076)

Event Date 01/17/2018

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2018 consumer did not return unused samples for further investigation.Aso reviewed records of biocompatibility tests on materials used to manufacture the same type of product.Refer to section for further details.

Event Description

Consumer reported that product caused skin irritation on her nose.She wore the product for about 8 hours.

Manufacturer Narrative

As of 02/19/2018 consumer did not return unused samples for further investigation.Aso reviewed records of biocompatibility tests on materials used to manufacture the same type of product.As of 03/30/2018 received completed cir from the consumer with confirmation of the lot number and unused product.The correct product of this complaint is extra strength tan nasal strips.Suspect medical device was corrected.Unused returned product and retained samples were submitted to the lab for testing in addition to evaluate biocompatibility testing.(b)(4).

Event Description

Consumer reported that product caused skin irritation on her nose.She wore the product for about 8 hours.

• 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: 7308172
• MDR Text Key: 101340891
• Report Number: 1038758-2018-00005
• 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,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/12/2022
• Device Model Number: UPC#041260370755
• Device Catalogue Number: 20589
• Device Lot Number: 00077490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2017
• 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