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Specifics for FDA ISR 4340505

The following regards a person of unknown age who died 0000-00-00

Gender: person

ISR# 4340505

Demographic info

Image Number: 4340505-5
Event Date: 0000-00-00
Manufacturer recieved infomation on: 2004-04-02
FDA recieved report on: 2004-04-14
Type of Report Submitted: Expedited (15-Day)
Manufacturer Number: DE-SHR-04-023609
Name of Manufacturers Sending Report: Berlex Laboratories
This was not submitted under electronic submissions procedure for manufacturers
Date Report was Sent: 2004-04-13
Reporter's type of occupation: Physician
Death Date: 0000-00-00


Drugs Used

Mirena: Sequence #1004794525
This was the Primary Suspect Drug
Mirena is the validated trade name
it is unknown if reaction abated when drug therapy was stopped.
it is unknown if reaction recurred when drug therapy was restarted.
Drug experation date 0000-00-00
Verbatim NDA number 21225



Outcomes

Congenital Anomaly


Reactions

Trisomy 21, Pregnancy With Contraceptive Device, Pregnancy, Maternal Drugs Affecting Foetus, Iucd Complication, Complications Of Maternal Exposure To Therapeutic Drugs


Report Source

Other, Health Professional, Foreign