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

Model Number UPC681131112185

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

Patient Problem Abrasion (1689)

Event Date 11/14/2015

Event Type  Injury  

Manufacturer Narrative

Aso evaluated retained samples for adhesion properties on 12/07/2015 with no issues observed with the samples.In addition, aso evaluated returned samples by the end user for adhesion properties on 12/11/2015 with no issues observed with the samples.Also reviewed satisfactory biocompatibility reports on products manufactured with the same materials.

Event Description

End user reported that she has been using devices and these have caused the skin on her nose to break out in a real bad rash.She stated that is almost as if the first layer of her skin has come off.

• Brand Name: EQUATE
• Type of Device: EXTRA STRENGTH NASAL DILATOR 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: 5319656
• MDR Text Key: 34152020
• Report Number: 1038758-2015-00117
• 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: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/22/2020
• Device Model Number: UPC681131112185
• Device Catalogue Number: 553994071
• Device Lot Number: 37972
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2015
• 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
• Patient Age: 76 YR
• Patient Weight: 91