MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-23 for SMARTPLUG 500 manufactured by Medennium Inc.
[15324487]
Implantation of smartplugs in upper punctums (b)(6) 2013 due to marketed keratitis sicca. Lower punctums (b)(6) 2013. Noted pain swelling and edema of lower lids immediately post implantation. Right greater than left. Successfully irrigated left side, unsuccessful on the right side after three attempts. In (b)(6) 2014 underwent surgical retrieval of the right lower lid and sustained significant irritation and ephiphora. (b)(6) 2014 unsuccessful attempt at (b)(6) tube placement was tried and surgery was converted to a successful dacryocystorhinostomy.
Patient Sequence No: 1, Text Type: D, B5
[15550019]
From the reported events we can conclude that the smartplugs were implanted in the pt's upper punctum with no problem. Once implanted in the lower punctum there was an immediate negative response by the pt showing signs of pain, swelling and edema. This is very rare as it was not observed in the upper punctum two months prior ruling out potential allergic reaction. The immediate negative response which was more prominent on the lower right lid leads us to believe that there was previous obstruction (nslo) which was overcome by simple irrigation of the lower left lid but became a problem on the right side. The nslo was not caused by the device as it persisted after its surgical removal in (b)(6) 2014 and was only resolved after performance of dacryocystorhinostomy in (b)(6) of 2014. Since the product was removed we do not expect any further problems with the pt. This case is closed as no additional information can be expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031959-2014-00003 |
| MDR Report Key | 4397790 |
| Report Source | 05 |
| Date Received | 2014-12-23 |
| Date of Report | 2014-12-22 |
| Date of Event | 2014-11-01 |
| Date Mfgr Received | 2014-12-11 |
| Date Added to Maude | 2015-01-09 |
| 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 |
| Manufacturer Phone | 9497899000 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTPLUG |
| Product Code | LZU |
| Date Received | 2014-12-23 |
| Model Number | 500 |
| Catalog Number | 500 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2014-12-23 |