MAUDE Adverse Event Report: MEDENNIUM SMART PLUG

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Inflammation (1932); Pain (1994); Discharge (2225)

Event Type  Injury  

Event Description

I had medennium smart plugs inserted into both my lower canaliculi in 2003.One came out in my nose within a year.I assumed the other hand had eventually flushed through; though this was never verified.In (b)(6) 2013, i experienced complete blockage of my nld and have had chronic canaliculitis, epiphora, discharge, pain and photophobia for the 10 months since then.Oculoplastic surgeon concurs that it is due to a migrated smartplug.Canaliculotomy in (b)(6) 2014 failed to locate the plug.Will proceed to external dcr.

• Brand Name: SMART PLUG
• Type of Device: SMART PLUG
• Manufacturer (Section D): MEDENNIUM
• MDR Report Key: 4135454
• MDR Text Key: 18570854
• Report Number: MW5038411
• Device Sequence Number: 1
• 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: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 44 YR
• Patient Weight: 91