MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-04-19 for EAGLE PLUG1 3001 manufactured by Eagle Vision, Inc..
[21655045]
Patient had a punctum plug protruding from the puncta with a tissue growth around the punctum plug. The punctum plug was removed and the patient was treated with antibiotic drops. Patient reported to be in good condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034718-2013-00002 |
| MDR Report Key | 3084007 |
| Report Source | 05,06 |
| Date Received | 2013-04-19 |
| Date of Report | 2013-03-21 |
| Date of Event | 2013-03-18 |
| Date Mfgr Received | 2013-03-21 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2013-05-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 8500 WOLF LAKE DR. SUITE 110 |
| Manufacturer City | MEMPHIS TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | 9013807000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EAGLE PLUG1 |
| Generic Name | PUNCTUM PLUG |
| Product Code | LZU |
| Date Received | 2013-04-19 |
| Catalog Number | 3001 |
| Lot Number | 77120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EAGLE VISION, INC. |
| Manufacturer Address | MEMPHIS TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-04-19 |