MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-12-03 for EAGLE PLUG1 3001 manufactured by Eagle Vision, Inc..
[3180000]
Punctum plug was placed in patient for treatment of dry eye on (b)(6) 2012. Punctum plug was removed on (b)(6) 2012, reportedly due to pyrogenic granuloma. Patient treated with tobradex 4x/day for 1 week.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034718-2012-00003 |
| MDR Report Key | 2870145 |
| Report Source | 05 |
| Date Received | 2012-12-03 |
| Date of Report | 2012-11-06 |
| Date of Event | 2012-10-16 |
| Date Mfgr Received | 2012-11-06 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2012-12-13 |
| 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 Contact | MR. BILL GRAHAM |
| Manufacturer Street | 8500 WOLF LAKE DR. SUITE 110 |
| Manufacturer City | MEMPHIS TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| 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 | 2012-12-03 |
| Catalog Number | 3001 |
| Lot Number | 77120 |
| Device Expiration Date | 2016-12-01 |
| 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. Required No Informationntervention | 2012-12-03 |