MAUDE Adverse Event Report: MEDENNIUM, INC. SMARTPLUG; PUNCTUM PLUG

Model Number 500

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Inflammation (1932); Irritation (1941); Discharge (2225)

Event Type  Injury  

Event Description

Implantation of smartplugs in both lower punctum in 2003.One came out the nose within one year.In 2013 patient experienced complete blockage of nld, chronic canaliculitis, epiphora, discharge, pain and photophobia for 10 months.Canaliculotomy performed in 2014 failed to locate the plug.Will proceed with external dcr.

Manufacturer Narrative

From the reported event we can conclude that the smartplugs were implanted in the patient's lower punctum of both eyes with no problem.Within one year one of the plugs came out of the patient's nose according to the patient.Ten years later patient experienced complete blockage of the nld and has had chronic canaliculitis, epiphora, discharge, pain and photophobia for a period of 10 months.Oculoplastic surgeon concurs that is due to a migrated smartplug even though he/she did not implant the product not can he/she offer any evidence of this.Furthermore canaliculotomy in 2014 failed to locate the plug and now they are proceeding to perform external dcr.As experienced recently and described under report (b)(4) surgical removal of smartplug proved not to be the cause of the nlso because the situation persisted after its removal and the situation only resolved after the performance of dcr.Nslo can occur in patients independent to the presence or absence of punctum plugs.

• Brand Name: SMARTPLUG
• Type of Device: PUNCTUM PLUG
• Manufacturer (Section D): MEDENNIUM, INC.; 9 parker, suite 150; irvine CA 92618
• Manufacturer Contact: julian abadia ; 9 parker, suite 150; irvine, CA 92618
• MDR Report Key: 4593569
• MDR Text Key: 5629837
• Report Number: 2031959-2015-00001
• Device Sequence Number: 1
• Product Code: LZU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500
• Device Catalogue Number: 500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention