MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-10-30 for EAGLE PLUG1 3001 manufactured by Eagle Vision, Inc..
[3938705]
Physician reported the pt developed a pyrogenic granuloma in the inferior punctum of the lower lid. The plug was explanted and the pt was treated with lotemax every 2 hours for 3 days then 4 times a day for 3 weeks.
Patient Sequence No: 1, Text Type: D, B5
[11218414]
The pt's granuloma has been resolved with treatment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034718-2013-00005 |
| MDR Report Key | 3449649 |
| Report Source | 05 |
| Date Received | 2013-10-30 |
| Date of Report | 2013-10-03 |
| Date of Event | 2013-07-12 |
| Date Mfgr Received | 2013-10-03 |
| Device Manufacturer Date | 2012-05-01 |
| Date Added to Maude | 2013-11-06 |
| 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 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. BILL GRAHAM, MGR. |
| 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 | 2013-10-30 |
| Catalog Number | 3001 |
| Lot Number | 77308 |
| Device Expiration Date | 2017-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2013-10-30 |