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 2016-10-26 for REXALL UPC#017276227376 10072101 manufactured by Aso Llc.
[58416143]
Aso evaluated returned samples as well as retained samples of the same lot number. In addition, aso reviewed records of biocompatibility tests.
Patient Sequence No: 1, Text Type: N, H10
[58416144]
Consumer reported that nasal dilator gave her a straight black mark across her nose after 10 - 15 minutes of use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2016-00101 |
| MDR Report Key | 6058110 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-10-26 |
| Date of Report | 2016-09-27 |
| Date of Event | 2016-09-26 |
| Date Mfgr Received | 2016-09-27 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2016-10-26 |
| 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 | REXALL |
| Generic Name | CLEAR NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2016-10-26 |
| Model Number | UPC#017276227376 |
| Catalog Number | 10072101 |
| Lot Number | 00027731 |
| 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 | 2016-10-26 |