FORM FIT HYDROGEL CANALICULAR PLUG 6303

MAUDE Adverse Event Report

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..

Event Text Entries

[3889612] Pt developed canaliculitis after insertion of an oasis medical form fit hydrogel canalicular plug.
Patient Sequence No: 1, Text Type: D, B5


[10930349] Reported event: (b)(6) female presented to the practitioners office in (b)(6) 2012 with discharge in the lower right punctum. Product description: oasis medical form fit hydrogel plug. Product reference: 6303, product lot: not reported; date of initial procedure: (b)(6) 2011; date of complication: (b)(6) 2012; date removed: (b)(6) 2013; date reported ot oasis: (b)(6) 2013. Discussion: plug was successfully irrigated from the eye by the attending doctor with full resolution. 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


MAUDE Entry Details

Report Number2083373-2013-00005
MDR Report Key3284658
Report Source05
Date Received2013-08-05
Date of Report2013-08-01
Date of Event2013-07-10
Date Mfgr Received2013-07-10
Date Added to Maude2013-08-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactNICOLA HUBERT, MANAGER
Manufacturer Street514 S. VERMONT AVENUE
Manufacturer CityGLENDORA CA 91741
Manufacturer CountryUS
Manufacturer Postal91741
Manufacturer Phone6268525182
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameFORM FIT HYDROGEL CANALICULAR PLUG
Generic NameINTRACANALICULAR PLUG
Product CodeLZU
Date Received2013-08-05
Model Number6303
Catalog Number6303
Lot NumberNOT REPORTED
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOASIS MEDICAL, INC.
Manufacturer Address514 S. VERMONT AVENUE GLENDORA CA 91741 US 91741


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-08-05

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