MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-04-29 for GELLANSERT TEMPORARY PUNCTUM PLUG 0040 manufactured by Eagle Vision, Inc..
[4433987]
Physician reported that gellansert temporary punctum plugs were used on a prk pt post surgery. The plugs were placed in the pt to increase the retention of ocular medication. The pt has had persistent canaliculitis os. Pt is on a course of antibiotics (doxycycline) to see if symptoms improve.
Patient Sequence No: 1, Text Type: D, B5
[11885335]
It was reported that the forceps used for inserting the gellansert plugs were cleaned with alcohol wipes. This is the 3rd of 3 reports from the same reporter on the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034718-2014-00003 |
| MDR Report Key | 3788309 |
| Report Source | 01,05,06 |
| Date Received | 2014-04-29 |
| Date of Report | 2014-04-24 |
| Date Mfgr Received | 2014-03-24 |
| Date Added to Maude | 2014-05-06 |
| 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 |
| 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 | GELLANSERT TEMPORARY PUNCTUM PLUG |
| Generic Name | PUNCTUM PLUG |
| Product Code | LZU |
| Date Received | 2014-04-29 |
| Catalog Number | 0040 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-04-29 |