MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-06 for 23 GA HIGH SPEED VITRECTOMY CUTTER BL5623 manufactured by Bausch + Lomb.
| Report Number | 0001920664-2019-00185 |
| MDR Report Key | 8970373 |
| Date Received | 2019-09-06 |
| Date of Report | 2019-08-13 |
| Date of Event | 2019-08-12 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-09-06 |
| Device Manufacturer Date | 2018-12-19 |
| Date Added to Maude | 2019-09-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | SAINT LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 23 GA HIGH SPEED VITRECTOMY CUTTER |
| Product Code | HQE |
| Date Received | 2019-09-06 |
| Returned To Mfg | 2019-08-28 |
| Model Number | BL5623 |
| Catalog Number | BL5623 |
| Lot Number | W3473 |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-06 |