23 GA HIGH SPEED VITRECTOMY CUTTER BL5623

MAUDE Adverse Event Report

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.

MAUDE Entry Details

Report Number0001920664-2019-00185
MDR Report Key8970373
Date Received2019-09-06
Date of Report2019-08-13
Date of Event2019-08-12
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2019-09-06
Device Manufacturer Date2018-12-19
Date Added to Maude2019-09-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. JULI MOORE
Manufacturer Street3365 TREE COURT INDUSTRIAL BLV
Manufacturer CitySAINT LOUIS MO 63122
Manufacturer CountryUS
Manufacturer Postal63122
Manufacturer Phone6362263220
Single Use0
Previous Use Code0
Event Type3
Type of Report0

Device Details

Brand Name23 GA HIGH SPEED VITRECTOMY CUTTER
Product CodeHQE
Date Received2019-09-06
Returned To Mfg2019-08-28
Model NumberBL5623
Catalog NumberBL5623
Lot NumberW3473
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerBAUSCH + LOMB
Manufacturer AddressROCHESTER NY 14609 US 14609


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-06

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