MalfunctionFCD
E-Z BARIUM ENEMA TIP
Received Sep 19, 2000
Report 2432460-2000-00029 · MDR key 297557
Device
Generic name
Angled Enema Tip Device
Manufacturer
E-z-em, Inc.Model number
NACatalog number
UNK
Lot number
UNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Device induced
- Extravasation
- Internal Organ Perforation
- Perforation
Narrative
Description of Event or Problem
CASE OF PERFORATION OF THE RECTUM WITH HIGH MORBIDITY FROM BARIUM EXTRAVASATION. THE PERFORATING INVOLVED THE ANTERIOR RECTAL WALL.