MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-17 for SUPEREAGLE PUNCTUM PLUG 3130 manufactured by Eagle Vision, Inc..
[2928662]
Pt had 2 punctum plugs inserted on (b)(6) 2012. When the pt returned to the office on (b)(6) 2012, the pt's lid was swollen and had red conjuctiva. Both punctum plugs were removed. The pt was treated with lotemax. It was the o. D. 's opinion that this event was due to an allergic reaction.
Patient Sequence No: 1, Text Type: D, B5
[10033340]
No follow-up info is expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034718-2012-00001 |
| MDR Report Key | 2709281 |
| Report Source | 05,06 |
| Date Received | 2012-08-17 |
| Date of Report | 2012-07-18 |
| Date of Event | 2012-07-16 |
| Date Mfgr Received | 2012-07-18 |
| Date Added to Maude | 2012-08-23 |
| 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 | 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 | 9013807000 |
| Manufacturer G1 | EAGLE VISION, INC. |
| Manufacturer Street | 8500 WOLF LAKE DR. SUITE 110 |
| Manufacturer City | MEMPHIS TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38133 |
| 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 | 2012-08-17 |
| Catalog Number | 3130 |
| Lot Number | 77182 & 77170 |
| 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 | 8500 WOLF LAKE DR. SUITE 110 MEMPHIS TN 38133 US 38133 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-17 |