ABVISER-INTRA ABDOMINAL PRESSURE MONITOR DEVICE
Received Oct 10, 2013 · Event occurred Sep 23, 2013
Report 2243969-2013-00123 · MDR key 3449250
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Convatec IncModel number
ABV321Catalog number
ABV321
Lot number
121206
Product problems
- Deflation Problem
- No Device Output
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. A RECURRENCE IS LIKELY TO LEAD TO A SERIOUS INJURY/SERIOUS ILLNESS. A LACK OF DRAINAGE MAY BE AN INDICATION OF AN OBSTRUCTION TO THE FLOW OF URINE. IT IS REPORTED THAT THE ABVISER WAS DISCONTINUED FROM USE, AND REPLACED WITH A NEW ABVISER AUTOVALVE. THE PATIENT WAS NOT HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE. A RETURN SAMPLE IS NOT EXPECTED FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED. THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.
Description of Event or Problem
IT IS REPORTED THAT AFTER 1 DAY OF USE, NO URINE OUTPUT WAS EVIDENT IN THE BAG, AND THAT THE BALLOON WOULD NOT DEFLATE.