MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-05 for FORM FIT HYDROGEL CANALICULAR PLUG 6303 manufactured by Oasis Medical, Inc..
[3889143]
Patient developed canaliculitis after insertion of an oasis medical form fit hydrogel canalicular plug.
Patient Sequence No: 1, Text Type: D, B5
[10930126]
Reported event: (b)(6) female had form fit plugs inserted in the upper and lower punctum in (b)(6) 2013 who presented to the office with mucus discharge and mild pain in (b)(6) 2013. Product description: oasis medical form fit hydrogel plug. Product reference: 6303. Product lot: not reported. Date of initial procedure: (b)(6) 2013. Date of complication: (b)(6) 2013. Date removed: (b)(6) 2013. Date reported to oasis: (b)(6) 2013. Discussion: the punctum was irrigated in the office with full resolution in (b)(6) 2013 after antibiotic and steroid treatment was unsuccessful. The device was not returned for evaluation. No conclusion can be drawn as to the direct cause of the reported adverse event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2083373-2013-00007 |
| MDR Report Key | 3284649 |
| Report Source | 05 |
| Date Received | 2013-08-05 |
| Date of Report | 2013-08-01 |
| Date of Event | 2013-07-10 |
| Date Mfgr Received | 2013-07-10 |
| Date Added to Maude | 2013-08-23 |
| 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 | NICOLA HUBERT, MANAGER |
| Manufacturer Street | 514 S. VERMONT AVE. |
| Manufacturer City | GLENDORA CA 91741 |
| Manufacturer Country | US |
| Manufacturer Postal | 91741 |
| Manufacturer Phone | 6268525182 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORM FIT HYDROGEL CANALICULAR PLUG |
| Generic Name | INTRACANALICULAR PLUG |
| Product Code | LZU |
| Date Received | 2013-08-05 |
| Model Number | 6303 |
| Catalog Number | 6303 |
| Lot Number | NOT REPORTED |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OASIS MEDICAL, INC. |
| Manufacturer Address | 514 S. VERMONT AVE. GLENDORA CA 91741 US 91741 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-05 |