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

Model Number 500

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Inflammation (1932)

Event Date 01/01/2013

Event Type  Injury  

Event Description

Refer to (b)(4).

Manufacturer Narrative

From the reported events we can conclude that the smartplugs were implanted at least one year prior to the diagnosis of canaliculitis in left upper lid and ephiphora on left eye.It was after two years that the patient underwent surgical procedures to have the plugs removed.As reported in the literature some surgeons first choice of treatment is surgical removal while others treat the infections and only then when the swelling is down they remove the plug by irrigation or massaging.From the report all we can conclude is that the plugs have been removed and no longer present a potential risk of secondary infection to the pt.The case is closed and no additional info can be expected.

• Brand Name: SMARTPLUG
• Type of Device: PUNCTUM PLUG
• Manufacturer (Section D): MEDENNIUM, INC.; 9 parker; suite 150; irvine CA 92618
• Manufacturer Contact: 9 parker; suite 150; irvine, CA 92618 ; 9497899000
• MDR Report Key: 3929774
• MDR Text Key: 21999960
• Report Number: 2031959-2014-00001
• Device Sequence Number: 1
• Product Code: LZU
• Combination Product (y/n): N
• PMA/PMN Number: K022043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• 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: 06/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention