MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-05 for OASIS MEDICAL DISPOSBALE INSTRUMENTS 4225 manufactured by Oasis Medical.
| Report Number | 2083373-2020-00001 |
| MDR Report Key | 9794608 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-01-03 |
| Device Manufacturer Date | 2019-04-08 |
| Date Added to Maude | 2020-03-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. EDWARD SANTA ANNA |
| Manufacturer Street | 514 SOUTH VERMONT AVENUE |
| Manufacturer City | GLENDORA, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 3055400 |
| Manufacturer G1 | OASIS MEDICAL |
| Manufacturer Street | 514 SOUTH VERMONT AVENUE |
| Manufacturer City | GLENDORA, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OASIS MEDICAL DISPOSBALE INSTRUMENTS |
| Generic Name | LASIK IRRIGATOR, 6 SIDE PORTS |
| Product Code | KYG |
| Date Received | 2020-03-05 |
| Model Number | 4225 |
| Catalog Number | 4225 |
| Lot Number | D0419F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OASIS MEDICAL |
| Manufacturer Address | 514 S. VERMONT AVENUE GLENDORA, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-05 |