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 |