ABVISER-INTRA ABDOMINAL PRESSURE MONITOR DEVICE
Received May 29, 2014 · Event occurred May 2, 2014
Report 1049092-2014-00157 · MDR key 3908217
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Convatec Inc.Model number
ABV301Catalog number
ABV301
Lot number
130745
Product problems
- Blocked Connection
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. COMPLAINT HANDLING AND CAPA PROCEDURES.
Description of Event or Problem
IT IS REPORTED THAT THE AUTO VALVE DID NOT OPEN RESULTING IN NO URINE EFFLUX.