SMARTPLUG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-20 for SMARTPLUG manufactured by Medennium Inc..

Event Text Entries

[95619616] Seen by ophthalmologist for first eye infection. Treated with vigamox for 2 weeks. Infection resolved, then returned (b)(6). Tried to have smartplugs irrigated out. Referred to opthamolic plastic surgeon. Now scheduled for surgical procedure to see if the smartplugs are gone and to resolve the recurrent canaliculitis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5074150
MDR Report Key7138435
Date Received2017-12-20
Date of Report2017-12-19
Date of Event2017-05-01
Date Added to Maude2017-12-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationUNKNOWN
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSMARTPLUG
Generic NamePLUG PUNCTUM
Product CodeLZU
Date Received2017-12-20
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDENNIUM INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2017-12-20

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