MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-03-14 for SMARTPLUG 500 manufactured by Medennium, Inc..
[3250239]
A large size pyogenic granuloma left lower lid involving canaliculus and puncta. Purulent material expressed with pressure on right lower lid and canaliculus. S/p exc of pyogenic granuloma left lower lid. S/p irrigation of nasolacrimal system right lower lid and left lower lid. Pt placed on maxitrol ointment to left lower lid/puncta every 2 hours. Maxitrol solution four times a day right lower lid. Pt now doing well with no complaints. Photographs available if needed.
Patient Sequence No: 1, Text Type: D, B5
[10658247]
From the reported events we can conclude that the smartplugs were implanted at least 3 years prior to the event (based on the expiration date of the product). The pyogenic granuloma was removed and product was irrigated out. The pt was treated with maxitrol (ointment and solution) and the pt is doing well with no complaints. Since the product was removed we do not expect any further problems with the pt. This case is closed and no additional information can be expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031959-2013-00001 |
| MDR Report Key | 3040536 |
| Report Source | 05 |
| Date Received | 2013-03-14 |
| Date of Report | 2013-03-12 |
| Date Mfgr Received | 2013-02-22 |
| Device Manufacturer Date | 2008-03-31 |
| Date Added to Maude | 2013-04-18 |
| 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 STE 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 | 2013-03-14 |
| Model Number | 500 |
| Catalog Number | 500 |
| Lot Number | 073N |
| Device Expiration Date | 2010-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDENNIUM, INC. |
| Manufacturer Address | 9 PARKER STE 150 IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-14 |