OtherFCE

KENDALL ENEMA BAG

Received Sep 29, 2005 · Event occurred Aug 12, 2005

Report 9612030-2005-00024 · MDR key 646550

Device

Generic name

Enema Bag With Tubing

Manufacturer

Tyco Healthcare/kendall

Model number

Catalog number

145540

Lot number

UNK

Product problems

Unknown (for use when the device problem is not known)

Patient

Narrative

Description of Event or Problem

A CUSTOMER HAD A PROBLEM WITH AN ENEMA BAG WITH TUBING. SUSTAINED A RECTAL PERFORATION DURING CT SCAN OF ABDOMEN & PELVIC REQUIRING INSERTION OF RECTAL TUBE FOR ADMIN OF RECTAL CONTRAST.