MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-10-15 for EAGLE PLUGL 3001 manufactured by Eaglevision, Inc..
[19017158]
Physician reported general info about pts having irritation of the epithelial lining of the canaliculus, pyrogenic granulomas and a case where surgical intervention was required due to erosion of the punctum plug.
Patient Sequence No: 1, Text Type: D, B5
[19059817]
Multiple attempts were made by our (b)(4) distributor for add'l info. The office manager was not aware of any problems and the physician would not respond with event or pt info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034718-2013-00004 |
| MDR Report Key | 3424792 |
| Report Source | 05 |
| Date Received | 2013-10-15 |
| Date of Report | 2013-09-16 |
| Date Mfgr Received | 2013-09-16 |
| Date Added to Maude | 2013-10-24 |
| 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, QA/RA MGR |
| Manufacturer Street | 8500 WOLF LAKE DRIVE SUITE 110 |
| Manufacturer City | MEMPHIS TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | 9013807000 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EAGLE PLUGL |
| Generic Name | PUNCTUM PLUG |
| Product Code | LZU |
| Date Received | 2013-10-15 |
| Catalog Number | 3001 |
| 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 | EAGLEVISION, INC. |
| Manufacturer Address | MEMPHIS TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-10-15 |