APOTHECON NITRAZINE PAPER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-03 for APOTHECON NITRAZINE PAPER manufactured by Bristol Myers Squibb Co,.

Event Text Entries

[7827] Paper is discolored to an avacado green instead of yellow color it should be.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4000200
MDR Report Key11515
Date Received1994-02-03
Date of Report1993-04-07
Date Added to Maude1994-02-17
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 NameAPOTHECON NITRAZINE PAPER
Product CodeLNW
Date Received1994-02-03
Lot NumberPDE01
Device Expiration Date1997-05-01
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key11515
ManufacturerBRISTOL MYERS SQUIBB CO,
Manufacturer AddressPRINCETON NJ 08540 US


Patients

Patient NumberTreatmentOutcomeDate
10 1994-02-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.