MAUDE Adverse Event Report: ASO LLC DOLLAR GENERAL; NASAL DILAOTR

Model Number UPC 017276227376

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

Patient Problem Burning Sensation (2146)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

Aso reached out to the consumer three times with no response regarding the lot number or providing returned samples.Additional data: representative samples from retained samples from known lots that are comparable to the product were tested as summarized in this document.

Event Description

On (b)(6) 2015 - the end user reported that the device burnt her face and left a burn mark on her nose.

• Brand Name: DOLLAR GENERAL
• Type of Device: NASAL DILAOTR
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL 94139 0300
• 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: 5225906
• MDR Text Key: 31266506
• Report Number: 1038758-2015-00088
• 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: 10/02/2015

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: Lay User/Patient
• Device Model Number: UPC 017276227376
• Device Catalogue Number: 10072101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2015
• Initial Date FDA Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1