MalfunctionFEN
ABVISER AUTOVALVE IAP MONITORING DEVICE, POLE MOUNT
Received Nov 6, 2015
Report 1722554-2015-31299 · MDR key 5208146
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Wolfe Tory Medical IncModel number
ABV301Lot number
11003D
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE CONNECTION BETWEEN AUTO VALVE AND DRAIN BAG IS LEAKING.