MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-06-25 for SMARTPLUG 500 manufactured by Medennium, Inc..
[21999960]
Refer to (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[22342584]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031959-2014-00001 |
| MDR Report Key | 3929774 |
| Report Source | 00 |
| Date Received | 2014-06-25 |
| Date of Report | 2014-06-24 |
| Date of Event | 2013-01-01 |
| Date Mfgr Received | 2014-06-03 |
| Date Added to Maude | 2014-07-14 |
| 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 Street | 9 PARKER SUITE 150 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497899000 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTPLUG |
| Generic Name | PUNCTUM PLUG |
| Product Code | LZU |
| Date Received | 2014-06-25 |
| 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 | 2014-06-25 |