MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for OMNI GLAUCOMA TREATMENT SYSTEM manufactured by Omni / Sight Sciences, Inc..
[183869624]
Pt underwent a trabeculectomy procedure (b)(6) 2020. Experienced a possible omni surgical device product failure. Pt returned (b)(6) 2020 related to increased ocular pressure. Second procedure to insert express short on (b)(6) 2020 was successful. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093771 |
| MDR Report Key | 9839972 |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-01-27 |
| Date Added to Maude | 2020-03-17 |
| 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 | RISK MANAGER |
| 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 | OMNI GLAUCOMA TREATMENT SYSTEM |
| Generic Name | TRABECULOTOME |
| Product Code | HMZ |
| Date Received | 2020-03-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OMNI / SIGHT SCIENCES, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-16 |