MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-04-12 for FORM FIT HYDROGEL CANALICULAR PLUG 6303 manufactured by Oasis Medical, Inc..
[2729817]
Reported observation: pt developed canaliculitis after insertion of an oasis medical form fit hydrogel canalicular plug in the left eye. Product reference: 6306, product lot number: not reported, product inserted on: (b)(6) 2011, date of complication: (b)(6) 2012, reported to oasis medical inc on: (b)(4) 2012. Pt treated by attending dr with antibiotics. Attending dr was unable to irrigate the plug from the canaliculus. Pt referred to an oculoplastic surgeon.
Patient Sequence No: 1, Text Type: D, B5
[10059428]
Pt developed canaliculitis with granuloma os lower lid in the left eye requiring surgical treatment. Attempts made to flush the plug from the canaliculus were unsuccessful. The canaliculus was not checked for patency prior to insertion of the oasis medical form fit hydrogel plug. After the attempted canalicular flush and topical antibiotic therapy was unsuccessful the pt was referred to an oculoplastic surgeon. The surgeon surgically removed the granuloma and what appeared to be a residual plug. The issue was resolved for the pt. The pt had an oasis medical form fit hydrogel plug inserted into both the right and left canaliculus. The pt has had no adverse event in the right lower puncta/nasolacrimal duct.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2083373-2012-00001 |
| MDR Report Key | 2629648 |
| Report Source | 05 |
| Date Received | 2012-04-12 |
| Date of Report | 2012-04-11 |
| Date of Event | 2012-03-12 |
| Date Mfgr Received | 2012-03-12 |
| Date Added to Maude | 2012-08-02 |
| 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, MGR |
| Manufacturer Street | 514 SOUTH 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 | 2012-04-12 |
| Model Number | 6303 |
| Catalog Number | 6303 |
| Lot Number | NOT REPORTED |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OASIS MEDICAL, INC. |
| Manufacturer Address | 514 SOUTH VERMONT AVE. GLENDORA CA 91741 US 91741 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-12 |