MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-02-18 for SMARTPLUG 500 manufactured by Medennium, Inc..
[5629837]
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.
Patient Sequence No: 1, Text Type: D, B5
[13053541]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031959-2015-00001 |
| MDR Report Key | 4593569 |
| Report Source | 00 |
| Date Received | 2015-02-18 |
| Date of Report | 2015-02-17 |
| Date Mfgr Received | 2015-01-20 |
| Date Added to Maude | 2015-03-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULIAN ABADIA |
| Manufacturer Street | 9 PARKER, SUITE 150 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTPLUG |
| Generic Name | PUNCTUM PLUG |
| Product Code | LZU |
| Date Received | 2015-02-18 |
| Model Number | 500 |
| Catalog Number | 500 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDENNIUM, INC. |
| Manufacturer Address | 9 PARKER, SUITE 150 IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-18 |