MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-05-24 for SMART PLUG 500 manufactured by Medennium, Inc..
[17960459]
From the med records belonging to the primary physician, we observed that several irrigation attempts were performed in the upper puncta yielding indications that the lacrimal sys was clear, "fluid flows freely". In this specific case, the combination of a cauterization of the lower puncta with use of silicone plugs in the upper puncta followed by smart plugs ni the upper puncta further complicates the true cause of infection and epiphora. This is the first case we have encountered of a combination procedure of a cauterization in the lower puncta and a smart plug occlusion in the upper puncta. This combination may further complicate the effective irrigation of smart plugs. The fact that there is no med record indicating that the go plug's (engle vision) were actually removed leaves the question of whether they fell out or migrated into the puncta. This is further evidenced by the pathology report that the remnants of extracted material were twice the size of a fully expanded smart plug and more in line with a typical silicone plug diameter. Regardless of what the punctal plug was, the surgical procedure has resolved the situation of epiphora and infection and they no longer present a risk to the pt. This case is now closed and no add'l info can be expected.
Patient Sequence No: 1, Text Type: N, H10
[17972282]
A pt with previous history of radial keratotomy, corneal ulcers, and sjogrens syndrome receives smart plugs lot #33328 in lower puncta lll and rll on (b)(6)-2003. On (b)(6) 2004, pt signs consent for irrigation and probing of lower puncta and the pt has go plugs (eagle vision silicone headed plugs) inserted in upper puncta. On (b)(6)-2004, pt signs consent for cauterization of lower puncta. Risks are clearly defined on form. On (b)(6)-2004, pt receives smart plugs lot #40248 in upper puncta. On (b)(6) 2005, after the pt reports epiphora, the dr irrigates and probes the upper puncta and states that the fluid flows freely. On (b)(6) of 2008, an oculoplastic surgeon diagnosed pt with a severe infection on the upper puncta and determined plugs were still in the upper puncta. The doctor performs a canalicuostomy to remove the upper plugs, scar tissue and re-construct the previously cauterized lower puncta. Following the surgery, the pt had immediate relief, the eyes stopped tearing and she no longer suffered from infections.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031959-2011-00002 |
| MDR Report Key | 2170019 |
| Report Source | 05 |
| Date Received | 2011-05-24 |
| Date of Report | 2011-05-23 |
| Date of Event | 2008-05-01 |
| Date Mfgr Received | 2011-05-16 |
| Device Manufacturer Date | 2004-06-09 |
| Date Added to Maude | 2011-07-25 |
| 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 | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART PLUG |
| Generic Name | PUNCTAL PLUG |
| Product Code | LZU |
| Date Received | 2011-05-24 |
| Model Number | 500 |
| Catalog Number | 500 |
| Lot Number | 141J |
| Device Expiration Date | 2006-05-09 |
| 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 | 2011-05-24 |