MAUDE Adverse Event Report: ASO LLC DOLLAR GENERAL REXALL; NASAL DILATOR DOUBLE BRIDGE CLEAR

Model Number UPC017276227376

Device Problem Failure to Obtain Sample (2533)

Patient Problem Bruise/Contusion (1754)

Event Date 12/18/2015

Event Type  Injury  

Manufacturer Narrative

Aso was unable to perform testing on product from same lot number as consumer had disposed of product and could not provide a lot number or samples.However, aso has reviewed records of biocompatibility tests performed on materials used to manufacture the same type of products.Aso will continue to monitor complaints received for this type of product.Consumer disposed of device.

Event Description

Consumer reported that device left a large bruise on her nose.She also claims that her nose is hurting although she is not sure if this is because of the device or because she is sick.

• Brand Name: DOLLAR GENERAL REXALL
• Type of Device: NASAL DILATOR DOUBLE BRIDGE CLEAR
• 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: 5391843
• MDR Text Key: 36848367
• Report Number: 1038758-2016-00006
• 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: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC017276227376
• Device Catalogue Number: 10072101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1