SUPER XL ENEMA BAG SYSTEM 8925

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-06 for SUPER XL ENEMA BAG SYSTEM 8925 manufactured by E-z-em, Inc..

Event Text Entries

[12708] Placement of enema tube in rectum perforated rectum. Upon extraction of the enema tip, the balloon was reinflated, demonstrating an unevenly inflated balloon.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1005028
MDR Report Key19442
Date Received1995-02-06
Date of Report1995-02-01
Date of Event1995-01-27
Date Added to Maude1995-02-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRADIOLOGIC TECHNOLOGIST
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSUPER XL ENEMA BAG SYSTEM
Product CodeFGD
Date Received1995-02-06
Catalog Number8925
Lot Number29248925
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key19356
ManufacturerE-Z-EM, INC.
Manufacturer AddressWESTBURY NY 11590 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 1995-02-06

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