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..
[16379989]
Reported event: patient developed chronic canaliculitis in the left eye. Product reference: 6303. Product lot number: lh0810a. Product inserted on: (b)(6) 2011. Date of complication: (b)(6) 2012. Reported to oasis medical, inc. On (b)(6) 2013. Discussion: 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 patient was referred to an oculoplastic surgeon. The surgeon surgically removed the granuloma and what appeared to be a residual plug. Culture of the removed device showed actinomyces israelii. The issue was resolved for the patient. 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
[16595794]
Reported observation: patient developed chronic canaliculitis after insertion of an oasis medical form fit hydrogel canalicular plug in the left eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083373-2013-00002 |
| MDR Report Key | 3284646 |
| Report Source | 05 |
| Date Received | 2013-08-05 |
| Date of Report | 2013-08-01 |
| Date of Event | 2013-07-09 |
| Date Mfgr Received | 2012-03-12 |
| 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 | LH0810A |
| ID Number | NA |
| Device Expiration Date | 2013-08-31 |
| 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 |