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 2017-12-01 for MEMBER'S MARK UPC#078742094656 614388119 manufactured by Aso Llc.
[93501742]
As of 12/01/2017 consumer did not return unused samples for further investigation. Aso reviewed records of biocompatibility tests, latex screening on adhesive and adhesion properties on samples associated with the product. Refer to section for further details.
Patient Sequence No: 1, Text Type: N, H10
[93501743]
Consumer reported that product caused him serious under eye pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2017-00046 |
| MDR Report Key | 7076102 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-12-01 |
| Date of Report | 2017-11-06 |
| Date of Event | 2017-11-03 |
| Date Mfgr Received | 2017-11-06 |
| Date Added to Maude | 2017-12-01 |
| 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 | MEMBER'S MARK |
| Generic Name | EXTRA STRENGTH NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2017-12-01 |
| Model Number | UPC#078742094656 |
| Catalog Number | 614388119 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-12-01 |