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 2019-02-28 for EQUATE UPC#681131112185 553994071 manufactured by Aso Llc.
[137451680]
As of (b)(6) 2019 retained samples were submitted to the lab for testing in addition to review records of biocompatibility tests. Unable to confirm the customer's specific issue due to the verbiage provided, the customer could not be contacted.
Patient Sequence No: 1, Text Type: N, H10
[137451681]
The report received from the reporting agency noted the following: " patient claims the nasal strip is causing her to spread wide" and medical attention will be sought.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2019-00007 |
| MDR Report Key | 8379449 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-02-28 |
| Date of Report | 2019-01-29 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2019-01-29 |
| Device Manufacturer Date | 2018-12-07 |
| Date Added to Maude | 2019-02-28 |
| 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 NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2019-02-28 |
| Model Number | UPC#681131112185 |
| Catalog Number | 553994071 |
| Lot Number | 00097395 |
| 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 | 1. Other | 2019-02-28 |