AUTOMATIC DISPENSER FOR BARIUM UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-20 for AUTOMATIC DISPENSER FOR BARIUM UNKNOWN manufactured by E-z-em.

Event Text Entries

[19161566] During barium enema on male pt, the automatic dispenser for barium caught on fire and immediately disconnected. No pt harm. Procedure was completed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4000030
MDR Report Key10493
Date Received1993-08-20
Date of Event1993-08-20
Date Added to Maude1993-12-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameAUTOMATIC DISPENSER FOR BARIUM
Product CodeFCD
Date Received1993-08-20
Model NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key10493
ManufacturerE-Z-EM
Manufacturer Address*


Patients

Patient NumberTreatmentOutcomeDate
10 1993-08-20

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