MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-05-23 for SUPEREAGLE PUNCTUM PLUG UNK manufactured by Eagle Vision, Inc..
[4657090]
Physician reported a granuloma around the punctum plug that caused it to extrude onto the lower lid of the pt.
Patient Sequence No: 1, Text Type: D, B5
[11814398]
Requests for additional patient and product info have been submitted. If additional info is received a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034718-2014-00004 |
| MDR Report Key | 3843617 |
| Report Source | 05,07 |
| Date Received | 2014-05-23 |
| Date of Report | 2014-05-23 |
| Date Mfgr Received | 2014-04-27 |
| Date Added to Maude | 2014-06-03 |
| 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 | 0 |
| 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 | SUPEREAGLE PUNCTUM PLUG |
| Generic Name | PUNCTUM PLUG |
| Product Code | LZU |
| Date Received | 2014-05-23 |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 2014-05-23 |