MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-11-17 for SUPEREAGLE LARGE PUNCTUM PLUG 3132 manufactured by Eagle Vision, Inc..
[16001236]
Pt developed granulation tissue around the plug that caused the extrusion of the plug. The plug then rubbed the cornea and conjunctiva causing red eye and foreign body sensation. The physician excised the granulation tissue and plug. Pt received no add'l treatment.
Patient Sequence No: 1, Text Type: D, B5
[16065208]
During a discussion with the physician it was determined that he was not gauging the puncta prior to selecting and inserting punctum plugs. The ifu states to gauge and puncta to determine the proper size plug. A gauge was sent to the physician.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034718-2014-00006 |
| MDR Report Key | 4273037 |
| Report Source | 05 |
| Date Received | 2014-11-17 |
| Date of Report | 2014-10-19 |
| Date of Event | 2014-10-04 |
| Date Mfgr Received | 2014-10-19 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2014-11-25 |
| 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, QA/RA MGR. |
| Manufacturer Street | 8500 WOLF LAKE DR. SUITE 110 |
| Manufacturer City | MEMPHIS TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | 9013807050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPEREAGLE LARGE PUNCTUM PLUG |
| Generic Name | PUNCTUM PLUG |
| Product Code | LZU |
| Date Received | 2014-11-17 |
| Catalog Number | 3132 |
| Lot Number | 77986 |
| 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 | 2014-11-17 |