MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-09 for SELF-THREADING MONOKA S1.1810U manufactured by Fci Opthalmics, Inc..
[101977061]
Patient Sequence No: 1, Text Type: N, H10
[101977062]
Patient was in surgery for a tear duct probe of the right eye. Physician inserted the ritleng tube into the right eye and upon positioning it, the tube broke in half. Physician removed the tube and proceeded to put in new tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7326585 |
| MDR Report Key | 7326585 |
| Date Received | 2018-03-09 |
| Date of Report | 2018-03-05 |
| Date of Event | 2018-02-28 |
| Report Date | 2018-03-05 |
| Date Reported to FDA | 2018-03-05 |
| Date Reported to Mfgr | 2018-03-05 |
| Date Added to Maude | 2018-03-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | 3 |
| Brand Name | SELF-THREADING MONOKA |
| Generic Name | PLUG, PUNCTUM |
| Product Code | LZU |
| Date Received | 2018-03-09 |
| Model Number | S1.1810U |
| Catalog Number | S1.1810U |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FCI OPTHALMICS, INC. |
| Manufacturer Address | CLINICAL RESEARCH CONSULTANTS, INC. 3308 JEFFERSON AVE CINCINNATI OH 45220 US 45220 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-09 |