ABVISER-INTRA ABDOMINAL PRESURE MONITOR DEVI
Received Sep 7, 2013 · Event occurred Sep 2, 2013
Report 2243969-2013-00112 · MDR key 3452960
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Convatec IncModel number
ABV330Catalog number
ABV330
Lot number
UNK
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. A RECURRENCE IS LIKELY TO LEAD TO A SERIOUS INJURY/SERIOUS ILLNESS. A LACK OF DRAINAGE AND BULGING THE URINARY CATHETER MAY BE AN INDICATION OF AN OBSTRUCTION TO THE FLOW OF URINE. THE PT WAS NOT HARMED AS A RESULT OF THIS MALFUNCTION. NO ADD'L INFO HAS BEEN PROVIDED TO DATE. A RETURN SAMPLE IS EXPECTED FOR EVAL. SHOULD ADD'L INFO BE REC'D, A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem
RPTR STATES THERE WERE NO SIGNS OF FLUID DRAINING FROM CATHETER, BUT FOLEY CATHETER APPEARED TO BE EXPANDING AND BULGING.