MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-07-15 for EAGLE PLUG1 3001 manufactured by Eaglevision, Inc..
[16082865]
Physician reported that he inserted 2 punctum plugs into a patient after properly gauging the punctas. / at a follow-up appointment he found a pyogenic granuloma in one of the punctas. The plug was removed and the patient treated with dexamethasone for 10 days. The granuloma has almost completely resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034718-2014-00005 |
| MDR Report Key | 4088123 |
| Report Source | 05 |
| Date Received | 2014-07-15 |
| Date of Report | 2014-06-16 |
| Date of Event | 2014-04-30 |
| Date Mfgr Received | 2014-06-16 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2014-09-16 |
| 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 |
| 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 | 2014-07-15 |
| Catalog Number | 3001 |
| Lot Number | 76987 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EAGLEVISION, INC. |
| Manufacturer Address | MEMPHIS TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-15 |