MAUDE Adverse Event Report: MEDENNIUM SMART PLUG

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Inflammation (1932)

Event Date 01/23/2013

Event Type  Injury  

Event Description

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.

• Brand Name: SMART PLUG
• Type of Device: SMART PLUG
• Manufacturer (Section D): MEDENNIUM
• MDR Report Key: 3795494
• MDR Text Key: 4478231
• Report Number: MW5035940
• Device Sequence Number: 3
• Product Code: LZU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/01/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 72