MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-25 for SMART PLUG manufactured by Medennium.
[18570854]
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.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5038411 |
MDR Report Key | 4135454 |
Date Received | 2014-09-25 |
Date of Report | 2014-09-25 |
Date Added to Maude | 2014-10-03 |
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 |
Brand Name | SMART PLUG |
Generic Name | SMART PLUG |
Product Code | LZU |
Date Received | 2014-09-25 |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDENNIUM |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Deathisabilit | 2014-09-25 |