FORM FIT HYDROGEL CANALICULAR PLUG
Received Aug 5, 2013 · Event occurred Jul 9, 2013
Report 2083373-2013-00003 · MDR key 3284645
Device
Generic name
Intracanalicular Plug
Manufacturer
Oasis Medical, Inc.Model number
6303Catalog number
6303
Lot number
NOT REPORTED
Product problems
- Insufficient Device Problem Information
Patient
UNK
- Unspecified Infection
Narrative
Description of Event or Problem
REPORTED OBSERVATION: PATIENT DEVELOPED CHRONIC CANALICULITIS AFTER INSERTION OF AN OASIS MEDICAL FORM FIT HYDROGEL CANALICULAR PLUG.
Additional Manufacturer Narrative
REPORTED EVENT: PATIENT DEVELOPED CHRONIC CANALICULITIS. PRODUCT REFERENCE: 6303. PRODUCT LOT NUMBER: NOT REPORTED. PRODUCT INSERTED ON: NOT REPORTED. DATE OF COMPLICATION: NOT REPORTED. REPORTED TO OASIS MEDICAL, INC. ON (B)(6) 2013. DISCUSSION: THE INITIAL REPORTER WAS CONTACTED TO REQUEST CASE SPECIFIC INFORMATION. OASIS WAS ADVISED THAT THE OFFICE WAS TOO BUSY TO PROVIDE THE REQUESTED INFORMATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO CONCLUSION CAN BE DRAWN AS TO THE DIRECT CAUSE OF THE REPORTED ADVERSE EVENT.