MAUDE Adverse Event Report: ASO LLC TOPCO; NASAL DILATOR 4-TOUCH CLEAR

Model Number UPC036800402614

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

Patient Problems Bruise/Contusion (1754); Scar Tissue (2060)

Event Date 01/09/2016

Event Type  Injury  

Manufacturer Narrative

As of 2/8/2016 aso has not received returned samples from consumer or store.Aso has conducted testing on retained samples of the same lot number as well as reviewed biocompatibility test records.Refer to report for further details.

Event Description

Consumer reported that device is scarring and brusing her nose.

• Brand Name: TOPCO
• Type of Device: NASAL DILATOR 4-TOUCH 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: 5417222
• MDR Text Key: 37712515
• Report Number: 1038758-2016-00008
• 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: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/18/2019
• Device Model Number: UPC036800402614
• Device Catalogue Number: 177637
• Device Lot Number: 22241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2014
• 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