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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASO LLC EQUALINE; NASAL DILATOR
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ASO LLC EQUALINE; NASAL DILATOR Back to Search Results
Model Number UPC 4116345025
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Irritation (2076)
Event Type  Injury  
Event Description
On (b)(6) 2015 the end user reported that the device caused an allergic reaction, her doctor stated that the device caused infection in her eye (the device was holding up her eyelid).
 
Manufacturer Narrative
Conclusions not completed, unable to confirm with the user if product was intentionally misused.Product is not designed for holding eye-lid.Follow-up report shall be sent.
 
Manufacturer Narrative
(b)(4).The end user provided additional information stating that the event remediated, symptoms corrected after she stopped using the product.
 
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Brand Name
EQUALINE
Type of Device
NASAL DILATOR
Manufacturer (Section D)
ASO LLC
sarasota FL
Manufacturer Contact
300 sarasota center blvd.
sarasota, FL 34240
MDR Report Key4810535
MDR Text Key5925830
Report Number1038758-2015-00016
Device Sequence Number1
Product Code LWF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative,company representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date11/03/2019
Device Model NumberUPC 4116345025
Device Catalogue Number7852163
Device Lot Number21906
Was Device Available for Evaluation? No
Date Manufacturer Received03/20/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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