InjuryFEN
ABVISER AUTOVALVE IAP MONITORING DEVICE, PATIENT MOUNT
Received Nov 5, 2015
Report 1722554-2015-31258 · MDR key 5205307
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Wolfe Tory Medical IncModel number
ABV601Lot number
120529
Product problems
- No Flow
Patient
Not reported
- Urinary Retention
Narrative
Additional Manufacturer Narrative
CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).
Description of Event or Problem
CUSTOMER REPORTED THAT ON COUPLE OCCASIONS AUTOVALVE FAILED TO DO IT'S WORK AND RESULTED WITH RETENTION OF FLUID IN PATIENTS BLADDER. ON ONE OCCASION IT RESULTED WITH RETENTION OF 1.5L OF FLUID WHICH NEARLY CAUSED SERIOUS COMPLICATIONS.