ABVISER-INTRA ABDOMINAL PRESSURE MONITOR DEVI
Received Jan 2, 2014 · Event occurred Dec 4, 2013
Report 2243969-2014-00003 · MDR key 3697329
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Covatec IncModel number
ABV320Catalog number
ABV320
Lot number
UNK
Product problems
- No Device Output
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE FOLLOWING COMPLAINT WAS REPORTED: A NURSE WHO WAS RECORDING URINE OUTPUT NOTICED THERE WAS NO URINE IN FOLEY BAG UPON ASSESSMENT. URINE BEGAN FLOWING AGAIN AS SOON AS ABVISER WAS DISCONTINUED.
Additional Manufacturer Narrative
BASED ON THE INFO PROVIDED THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. COMPLAINT STATES NEW ABVISER WAS NOT PLACED AS END USER WAS STABILIZING AT THAT TIME. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(6) 2014. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.