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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASO LLC EQUATE NASAL DILATORS CLEAR DOUBLE BRIDGE 26 CT.
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ASO LLC EQUATE NASAL DILATORS CLEAR DOUBLE BRIDGE 26 CT. Back to Search Results
Model Number UPC: 681131068420
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abrasion (1689)
Event Date 06/25/2015
Event Type  Injury  
Event Description
On 06/25/2015, the end user alleged that the device is taking her skin off when removing the product.
 
Manufacturer Narrative
The returned samples of the device are for a different type of nasal dilator that is manufactured by aso and sold to (b)(4).
 
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Brand Name
EQUATE NASAL DILATORS CLEAR DOUBLE BRIDGE 26 CT.
Type of Device
NASAL DILATOR
Manufacturer (Section D)
ASO LLC
sarasota FL
Manufacturer Contact
300 sarasota center blvd.
sarasota, FL 34240
9413790300
MDR Report Key4948752
MDR Text Key6640662
Report Number1038758-2015-00054
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,Followup
Report Date 07/27/2015
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 Lay User/Patient
Device Expiration Date04/11/2020
Device Model NumberUPC: 681131068420
Device Catalogue Number551594655
Device Lot Number28383
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/25/2015
Initial Date FDA Received07/27/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/14/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2015
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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