MAUDE Adverse Event Report: ASO LLC EQUATE; NASAL DILATOR DOUBLE BRIDGE CLEAR

Model Number UPC681131068420

Device Problem Failure to Obtain Sample (2533)

Patient Problem Abrasion (1689)

Event Date 11/17/2015

Event Type  Injury  

Manufacturer Narrative

Aso reviewed lab reports of retained samples from a different lot number for adhesion properties with no issues observed with the samples.In addition, also reviewed satisfactory biocompatibility reports on products manufactured with the same materials.

Event Description

End user reported that device ripped off a piece of her skin on her nostril.No medical attention was sought out.

• Brand Name: EQUATE
• 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: 5285799
• MDR Text Key: 33166083
• Report Number: 1038758-2015-00114
• 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: 11/17/2015

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: No Information
• Device Model Number: UPC681131068420
• Device Catalogue Number: 552632419
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 78 YR
• Patient Weight: 68