25G BI-B COMBINED ELITE W WF SE5525WVB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-12 for 25G BI-B COMBINED ELITE W WF SE5525WVB manufactured by Bausch + Lomb.

Event Text Entries

[183174841] The sterilization and lot history records were reviewed and found to be acceptable. Investigation ongoing.
Patient Sequence No: 1, Text Type: N, H10


[183174842] A bi-blade cutter stopped with the cut door open. Aspiration continued with a problem from the external hole. The cutter was replaced from a new pack. There was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001920664-2020-00051
MDR Report Key9824305
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-03-12
Date of Report2020-02-22
Date of Event2020-02-20
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-22
Date Added to Maude2020-03-12
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 63121
Manufacturer CountryUS
Manufacturer Postal63121
Manufacturer Phone6362263220
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand Name25G BI-B COMBINED ELITE W WF
Generic NameUNIT, PHACOFRAGMENTATION
Product CodeHQC
Date Received2020-03-12
Model NumberSE5525WVB
Catalog NumberSE5525WVB
Lot NumberW3539
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerBAUSCH + LOMB
Manufacturer AddressROCHESTER NY 14609 US 14609

Device Sequence Number: 101

Product Code---
Date Received2020-03-12
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-12

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