EQUATE UPC681131112185 553994071

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-06-17 for EQUATE UPC681131112185 553994071 manufactured by Aso Llc.

Event Text Entries

[47619701] Aso has not received returned samples from the consumer. However, aso obtained a lot number from the consumer and was able to perform evaluation for adhesion properties on retained samples of the same lot number on (b)(6) 2016. Consumer has reported that she experienced some redness which might have contributed to torn skin, however, aso advises consumers not to use product on irritated or sunburned skin. While every attempt is made to develop a product that meets all users' needs, there is always a possibility that some consumers may be sensitive to certain adhesives, materials, foods and medicines that can potentially cause irritation to the skin. Aso has reviewed the customer complaints database for adverse events on the same lot number and confirmed that this was the only complaint received since the manufactured date of this lot number. Aso will follow-up with the consumer accordingly to obtain returned samples of the product and follow-up on this report if necessary.
Patient Sequence No: 1, Text Type: N, H10


[47619702] Consumer reported that the nasal dilator extra strength clear took her skin off. In addition, she stated that she used the product every night until she noticed redness and a line across the nose. Consumer reported that she would be seeking medical attention.
Patient Sequence No: 1, Text Type: D, B5


[50876309] Aso has not received returned samples from the consumer. However, aso obtained a lot number from the consumer and was able to perform evaluation for adhesion properties on retained samples of the same lot number on 05/26/2016. Consumer has reported that she experienced some redness which might have contributed to torn skin, however, aso advises consumers not to use product on irritated or sunburned skin. While every attempt is made to develop a product that meets all users' needs, there is always a possibility that some consumers may be sensitive to certain adhesives, materials, foods and medicines that can potentially cause irritation to the skin. Aso has reviewed the customer complaints database for adverse events on the same lot number and confirmed that this was the only complaint received since the manufactured date of this lot number. Aso will follow-up with the consumer accordingly to obtain returned samples of the product and follow-up on this report if necessary. Aso received unused returned samples from the consumer on 07/08/2016 and evaluated product for adhesion properties.
Patient Sequence No: 1, Text Type: N, H10


[50876310] Consumer reported that the nasal dilator extra strength clear took her skin off. In addition, she stated that she used the product every night until she noticed redness and a line across the nose. Consumer reported that she would be seeking medical attention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1038758-2016-00079
MDR Report Key5732414
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2016-06-17
Date of Report2016-07-08
Date of Event2016-05-18
Date Mfgr Received2016-07-08
Device Manufacturer Date2016-02-29
Date Added to Maude2016-06-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. FEDERICO JULIAO
Manufacturer Street300 SARASOTA CENTER BLVD.
Manufacturer CitySARASOTA FL 34240
Manufacturer CountryUS
Manufacturer Postal34240
Manufacturer Phone9413790300
Manufacturer G1ASO LLC
Manufacturer Street300 SARASOTA CENTER BLVD.
Manufacturer CitySARASOTA FL 34240
Manufacturer CountryUS
Manufacturer Postal Code34240
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEQUATE
Generic NameNASAL DILATOR EXTRA STRENGTH CLEAR
Product CodeLWF
Date Received2016-06-17
Model NumberUPC681131112185
Catalog Number553994071
Lot Number43542
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerASO LLC
Manufacturer Address300 SARASOTA CENTER BLVD. SARASOTA FL 34240 US 34240


Patients

Patient NumberTreatmentOutcomeDate
10 2016-06-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.