inforMED
MalfunctionFCD

EZEM

Received May 21, 2007 · Event occurred May 18, 2007

Report MW5001941 · MDR key 855193

Device

Generic name

Super Xl Enema System

Manufacturer

E-z-em Inc.

Catalog number

8925

Lot number

741022

Product problems

  • Inflation Problem

Patient

YR

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

ENEMA BAG:TIP BALLOON-PURPOSE IS TO INFLATE IN PT'S RECTUM. IN THIS CASE, 2 SEPARATE PRODUCTS DID NOT INFLATE AND WERE DISCARDED.