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

Model Number ABV601

Device Problem No Flow (2991)

Patient Problem Urinary Retention (2119)

Event Type  Injury  

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).

Event Description

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.

• Brand Name: ABVISER AUTOVALVE IAP MONITORING DEVICE, 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: 5205307
• MDR Text Key: 30546261
• Report Number: 1722554-2015-31258
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• 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

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/17/2015
• Device Model Number: ABV601
• Device Lot Number: 120529
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2012
• 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