MalfunctionGBT
UROLOGICAL
Received May 18, 2001
Report 2429473-2001-00067 · MDR key 334284
Device
Generic name
Rectal Balloon Catheter
Manufacturer
Rusch, Inc.Model number
NACatalog number
UNK
Lot number
UNK
Product problems
- Tears, rips, holes in device, device material
Patient
NA
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
CUSTOMER REPORTS THAT CATHETER IS UNABLE TO BE USED BECAUSE OF SMALL HOLES IN BALLOON.