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 2018-03-29 for EQUATE UPC#681131112185 553994071 manufactured by Aso Llc.
[103818754]
As of 03/27/2018 retained product was submitted to the lab for testing in addition to evaluate the biocompatibility studies. 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. There was no negative trend identified for the associated product.
Patient Sequence No: 1, Text Type: N, H10
[103818755]
Consumer submitted a complaint associated with equate extra strength clear nasal strips to fda. Consumer reported that she woke up with a swollen nose after using one strip for the first time overnight. Consumer also reported that the product tore off some of her skin and her nose is red. Fda has requested for the list of ingredients and manufacturer's name and address.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2018-00010 |
| MDR Report Key | 7381473 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-03-29 |
| Date of Report | 2018-03-03 |
| Date of Event | 2018-03-01 |
| Date Mfgr Received | 2018-03-03 |
| Device Manufacturer Date | 2017-08-05 |
| Date Added to Maude | 2018-03-29 |
| 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 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 | EXTRA STRENGTH CLEAR NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2018-03-29 |
| Model Number | UPC#681131112185 |
| Catalog Number | 553994071 |
| Lot Number | 00069431 |
| Device Availability | N |
| 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 | 2018-03-29 |