MAUDE Adverse Event Report: WOLFE TORY MEDICAL INC ABVISER AUTOVALVE IAP MONITORING WITH TRANSDUCER, PATIENT MOUNT; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number ABV320

Device Problem No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

It was reported that urinary autovalve did not drain the saline instilled in patient.The patient did not have any urine output.Staff believed the valve to be blocked.Discarded product and replaced with another.Not for sure how long the valve was closed.Patient did not have adverse effects although a fluid bolus was given for decreased urine output.Patient was transferred to an long term acute care facility.

• Brand Name: ABVISER AUTOVALVE IAP MONITORING WITH TRANSDUCER, PATIENT MOUNT
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): WOLFE TORY MEDICAL INC; 79 west 4500 south suite 18; salt lake city UT 84107
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5203996
• MDR Text Key: 30779258
• Report Number: 1722554-2015-31255
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ABV320
• Device Lot Number: 10505A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention