MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-20 for SMARTPLUG manufactured by Medennium Inc..
[95619616]
Seen by ophthalmologist for first eye infection. Treated with vigamox for 2 weeks. Infection resolved, then returned (b)(6). Tried to have smartplugs irrigated out. Referred to opthamolic plastic surgeon. Now scheduled for surgical procedure to see if the smartplugs are gone and to resolve the recurrent canaliculitis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074150 |
| MDR Report Key | 7138435 |
| Date Received | 2017-12-20 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-05-01 |
| Date Added to Maude | 2017-12-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SMARTPLUG |
| Generic Name | PLUG PUNCTUM |
| Product Code | LZU |
| Date Received | 2017-12-20 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDENNIUM INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-12-20 |