25GA ILLUMINATED DIRECTIONAL II LASER PROBE 55.48.25P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-17 for 25GA ILLUMINATED DIRECTIONAL II LASER PROBE 55.48.25P manufactured by Bausch + Lomb.

MAUDE Entry Details

Report Number0001932402-2020-00004
MDR Report Key9843654
Report SourceFOREIGN,USER FACILITY
Date Received2020-03-17
Date of Report2020-02-28
Date of Event2020-02-28
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-28
Date Added to Maude2020-03-17
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 CityST. LOUIS MO 63122
Manufacturer CountryUS
Manufacturer Postal63122
Manufacturer Phone6362263220
Manufacturer G1SYNERGETICS, INC.
Manufacturer Street3845 CORPORATE CENTRE DR.
Manufacturer CityOFALLON MO 63368
Manufacturer CountryUS
Manufacturer Postal Code63368
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand Name25GA ILLUMINATED DIRECTIONAL II LASER PROBE
Generic NamePHOTOCOAGULATOR AND ACCESSORIES
Product CodeHQB
Date Received2020-03-17
Model Number55.48.25P
Catalog Number55.48.25P
Lot NumberM0025234
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Sequence No1
Device Event Key0
ManufacturerBAUSCH + LOMB
Manufacturer AddressROCHESTER NY 14609 US 14609

Device Sequence Number: 101

Product Code---
Date Received2020-03-17
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-17

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