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

Model Number UPC681131068437

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

Patient Problem Abrasion (1689)

Event Date 11/11/2015

Event Type  Injury  

Manufacturer Narrative

Aso evaluated retained samples for adhesion properties on 11/19/2015 with no issues observed with the samples.In addition, aso evaluated returned samples by the end user for adhesion properties on 11/25/2015 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 device caused her skin from the right side of her nose to peel off when she peeled off the device.

• Brand Name: EQUATE
• 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: 5272605
• MDR Text Key: 32858663
• Report Number: 1038758-2015-00111
• 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: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/19/2020
• Device Model Number: UPC681131068437
• Device Catalogue Number: 552632418
• Device Lot Number: 34676
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2015
• 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: 63 YR
• Patient Weight: 49