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.
[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
| Report Number | 1038758-2016-00079 |
| MDR Report Key | 5732414 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-06-17 |
| Date of Report | 2016-07-08 |
| Date of Event | 2016-05-18 |
| Date Mfgr Received | 2016-07-08 |
| Device Manufacturer Date | 2016-02-29 |
| Date Added to Maude | 2016-06-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. FEDERICO JULIAO |
| Manufacturer Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA FL 34240 |
| Manufacturer Country | US |
| Manufacturer Postal | 34240 |
| Manufacturer Phone | 9413790300 |
| Manufacturer G1 | ASO LLC |
| Manufacturer Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA FL 34240 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34240 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EQUATE |
| Generic Name | NASAL DILATOR EXTRA STRENGTH CLEAR |
| Product Code | LWF |
| Date Received | 2016-06-17 |
| Model Number | UPC681131112185 |
| Catalog Number | 553994071 |
| Lot Number | 43542 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASO LLC |
| Manufacturer Address | 300 SARASOTA CENTER BLVD. SARASOTA FL 34240 US 34240 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-17 |