MAUDE Adverse Event Report: ASO LLC TARGET; NASAL DILATOR EXTRA STRENGTH

Model Number UPC017276226904

Device Problems Failure to Obtain Sample (2533); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burning Sensation (2146)

Event Date 03/23/2016

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2016 aso has not received any information from consumer regarding the device (upc, item number, batch number or returned samples).Aso is unable to evaluate samples of the same lot number.However, aso reviewed records of biocompatibility tests.

Event Description

Consumer reported that she got a burn on the nose after using the product.

Manufacturer Narrative

As of 4/22/2016 aso has not received any information from consumer regarding the device (upc, item number, batch number or returned samples).Aso is unable to evaluate samples of the same lot number.However, aso reviewed records of biocompatibility tests.Samples were returned to aso on 04/26/2016 for evaluation of the adhesion properties.Additionally, the customer has not reported additional medical complications related to this report since the initial complaint.Based on the information available at the time of this report, this issue appears to be a minor incident and not a serious injury.

Event Description

Consumer reported that she got a burn on the nose after using the product.

• Brand Name: TARGET
• Type of Device: NASAL DILATOR EXTRA STRENGTH
• 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 ; 9413790300
• MDR Report Key: 5598755
• MDR Text Key: 43350037
• Report Number: 1038758-2016-00057
• 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: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/21/2020
• Device Model Number: UPC017276226904
• Device Lot Number: 34933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2015
• 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