SYNERGETICS ENTRY SITE ALIGNMENT SYSTEM W/VALVE BL5240

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-06-29 for SYNERGETICS ENTRY SITE ALIGNMENT SYSTEM W/VALVE BL5240 manufactured by Bausch + Lomb.

Event Text Entries

[112743563] The sterilization and lot history records were reviewed and found to be acceptable. Report 1 of 7 see: 1932402-2018-00005, 00006, 00007, 00008, 00009, 00010.
Patient Sequence No: 1, Text Type: N, H10


[112743564] It was reported the patient developed endophthalmitis after a procedure in which bausch + lomb devices were used. The cause of the endophthalmitis has not been determined. Additional information regarding possible treatment and patient outcome has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001932402-2018-00004
MDR Report Key7650686
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-06-29
Date of Report2018-06-08
Date of Event2018-06-08
Device Manufacturer Date2017-11-02
Date Added to Maude2018-06-29
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
Manufacturer Street3845 CORPORATE CENTRE DRIVE
Manufacturer CityO''FALLON MO 63368
Manufacturer CountryUS
Manufacturer Postal Code63368
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYNERGETICS ENTRY SITE ALIGNMENT SYSTEM W/VALVE
Generic Name27GA VALVED ESA SYSTEM
Product CodeNGY
Date Received2018-06-29
Model NumberBL5240
Lot NumberM0013382
ID NumberNI
Device Expiration Date2019-05-08
OperatorPHYSICIAN ASSISTANT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAUSCH + LOMB
Manufacturer AddressROCHESTER NY 14609 US 14609


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-06-29

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