MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-23 for EAGLE VISION 0.6 MILLIMETER PLUG manufactured by Katena Products, Inc..
[118270652]
Product did not work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079381 |
| MDR Report Key | 7813295 |
| Date Received | 2018-08-23 |
| Date of Report | 2018-08-21 |
| Date Added to Maude | 2018-08-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | EAGLE VISION 0.6 MILLIMETER PLUG |
| Generic Name | LACRIMAL STENTS AND INTUBATION SETS |
| Product Code | OKS |
| Date Received | 2018-08-23 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | KATENA PRODUCTS, INC. |
| Brand Name | EAGLE VISION 0.6 MILLIMETER PLUG |
| Generic Name | LACRIMAL STENTS AND INTUBATION SETS |
| Product Code | OKS |
| Date Received | 2018-08-23 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENTEROPTYX OEM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-23 |