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

Model Number ABV301

Device Problem Leak/Splash (1354)

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 (b)(4).

Event Description

It was reported that the connection between auto valve and drain bag is leaking.

• Brand Name: ABVISER AUTOVALVE IAP MONITORING DEVICE, POLE 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: 5208146
• MDR Text Key: 30643052
• Report Number: 1722554-2015-31299
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ABV301
• Device Lot Number: 11003D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 11/06/2015
• 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