EYE KIT SPCK 944

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-06-01 for EYE KIT SPCK 944 manufactured by Alcon Laboratories, Inc..

Event Text Entries

[8863] When eye kits were used, it was noted that eye shields were not included in the kit as previously supplied.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1002288
MDR Report Key13668
Date Received1994-06-01
Date of Report1994-05-16
Date of Event1994-05-13
Date Added to Maude1994-06-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameEYE KIT
Product CodeHOY
Date Received1994-06-01
Catalog NumberSPCK 944
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key13666
ManufacturerALCON LABORATORIES, INC.
Manufacturer AddressFORT WORTH TX 76134 US


Patients

Patient NumberTreatmentOutcomeDate
10 1994-06-01

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