FDA Adverse Event
Other
Summary report: N
SMARTPLUG
MDR report key: 535020
·
Received July 16, 2004
Report
- Report Number
- 2031959-2004-00012
- Event Type
- Other
- Date Received
- July 16, 2004
- Report Date
- July 15, 2004
- Manufacturer
- MEDENNIUM, INC.
- Product Code
- LZU
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
"THE DOCTOR BELIEVES HE MAY HAVE HAD A CASE OF CANALICULITIS. HE STATED A PT RETURNED TO HIS OFFICE 6 MONTHS POST INSERTION OF SMARTPLUG WITH PUS PROTRUDING FROM THE VERTICAL CANAL. THE RIGHT EYE HAD SWELLING BY THE LID MARGIN AND THE PT REVEALED THERE HAD BEEN PUS X 3 WEEKS. THE PT HAD NO RELEVANT PREVIOUS HISTORY AND THE PHYSICIAN PUT THE PT ON AN ANTIBIOTIC. THE CASE RESOLVED AND THE PT HAS HAD NO REOCCURRENCES."
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 | 48 YR | Other |