MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-01-07 for FORM FIT HYDROGEL CANALICULAR PLUG 6303 manufactured by Oasis Medical, Inc..
[20746355]
Reported observation: pt developed canaliculitis after insertion of an oasis medical form fit hydrogel canalicular plug. (b)(4). Product lot number: unk. Product inserted on: unk. Date of complication: reported to oasis medical, inc. On (b)(6) 2010. Pt had noticeable puss and inflammation, doctor treated with antibiotics. Pt returned after treatment and the doctor was able to remove the plug from the canaliculus, the doctor expressed concerns for scar tissue with this pt.
Patient Sequence No: 1, Text Type: D, B5
[20814513]
The device was not returned for eval. Specific product lot info was not provided with the initial report of the complications. The date of plug insertion and removal was not reported with the initial report of complications. The attending doctor was able to irrigate the plug from the canaliculus. A request for case specific info has been requested from the reporting doctor. Supplemental info will be submitted when received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2083373-2010-00004 |
| MDR Report Key | 1960266 |
| Report Source | 05 |
| Date Received | 2011-01-07 |
| Date of Report | 2011-01-07 |
| Date of Event | 2009-12-10 |
| Date Mfgr Received | 2010-12-10 |
| Date Added to Maude | 2012-02-29 |
| 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 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 | 2011-01-07 |
| Model Number | 6303 |
| Catalog Number | 6303 |
| Lot Number | UNK |
| 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 S. VERMONT AVE. GLENDORA CA 91741 US 91741 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-01-07 |