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..
[22137159]
Physician reported that gellansert temporary punctum plugs were used on a prk patient post surgery. The plugs were placed in the patient to increase the retention of ocular medication. The patient has had persistent canaliculitis od. Patient has had irrigation of the canaliculus twice, but without full resolution of the symptoms.
Patient Sequence No: 1, Text Type: D, B5
[22208065]
It was reported that the forceps used for inserting the gellansert plugs were cleaned with alcohol wipes. This is the 2nd of 3 reports from the same reporter on the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034718-2014-00002 |
| MDR Report Key | 3788310 |
| 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 |