FDA Adverse Event
Other
Summary report: N
SMARTPLUG
MDR report key: 615146
·
Received June 15, 2005
Report
- Report Number
- 2031959-2005-00005
- Event Type
- Other
- Date Received
- June 15, 2005
- Report Date
- June 10, 2005
- Manufacturer
- MEDENNIUM, INC.
- Product Code
- LZU
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
"THE DR STATED THAT HE HAS SEEN ONE CASE OF CANALICULITIS RECENTLY. THE DR STATED HE INSERTED SMARTPLUG IN PT APPROX 1-1/2 YEARS AGO AND THE PT RETURNED RECENTLY WITH CANALICULITIS. THE DR SAID HE USED A TOPICAL ANTIBIOTIC AND FLUSHED/IRRIGATED THE PRODUCT WITHOUT INCIDENT. THE PT'S CASE HAS BEEN RESOLVED AFTER AN ADDITIONAL 1 WEEK OF ORAL ANTIBIOTICS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMARTPLUG | PUNCTUM PLUG | LZU | MEDENNIUM, INC. | MODEL 500 | 34420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other| R |