FDA Adverse Event
Other
Summary report: N
SMARTPLUG
MDR report key: 520390
·
Received April 9, 2004
Report
- Report Number
- 2031959-2004-00008
- Event Type
- Other
- Date Received
- April 9, 2004
- Report Date
- April 9, 2004
- Manufacturer
- MEDENNIUM, INC.
- Product Code
- LZU
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
"DR'S OFFICE REPORTED THAT A PT CAME IN, WAS DIAGNOSED WITH DRY EYE SYNDROME, WAS A PREVIOUS SILICONE PLUG USER AND SMARTPLUG WAS INSERTED AFTER PATENCY WAS ASSESSED. THE PT RETURNED A FEW DAYS LATER COMPLAINING OF PAIN IN THE RIGHT EYE AND WAS DIAGNOSED WITH AN INFECTION IN THAT EYE. DR PUT THE PT ON KEFLEX (DOSE AND REGIMEN UNKNOWN) AND THE PT IS TO RETURN IN A FEW DAYS FOR FOLLOW UP."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMARTPLUG | PUNCTUM PLUG | LZU | MEDENNIUM, INC. | MODEL 500 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |