SMART PLUG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-02 for SMART PLUG manufactured by Medennium.

Event Text Entries

[4478231] I had smartplugs, intracanalicular plugs by medennium, installed in my tear duct canaliculis (all 4 - both eyes, upper and lower eyelids) in (b)(6) 2011. In (b)(6) 2012, i was diagnosed with canaliculitis in left upper eyelid and epiphora in left eye. In (b)(6) 2013, i had a surgery cannaliculi repair, and removed one smart plug. In (b)(6) 2013, i had a dacryocystorhinostomy (dcr) surgery on my left eye tear duct blocked by migrated smart plug. In (b)(6) 2013, i was diagnosed with canaliculitis in my right upper eyelid, and i had a surgical procedure done - removal of foreign body from canaliculi - a smart plug was removed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5035940
• MDR Report Key: 3795494
• Date Received: 2014-05-02
• Date of Report: 2014-05-01
• Date of Event: 2013-01-23
• Date Added to Maude: 2014-05-08
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: SMART PLUG
• Generic Name: SMART PLUG
• Product Code: LZU
• Date Received: 2014-05-02
• Operator: LAY USER/PATIENT
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDENNIUM

Device Sequence Number: 2

• Brand Name: SMART PLUG
• Generic Name: SMART PLUG
• Product Code: LZU
• Date Received: 2014-05-02
• Operator: LAY USER/PATIENT
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MEDENNIUM

Device Sequence Number: 3

• Brand Name: SMART PLUG
• Generic Name: SMART PLUG
• Product Code: LZU
• Date Received: 2014-05-02
• Operator: LAY USER/PATIENT
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: MEDENNIUM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2014-05-02