MAUDE Adverse Event Report: CONVATEC, INC VISI-FLOW IRRIGATION STARTER SET 1 3/4"; IRRIGATOR, OSTOMY

Model Number 022800

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/14/2014

Event Type  malfunction  

Event Description

It was reported there were black, "mold-like" spots along the irrigation tube, which appeared like mold spots.

Manufacturer Narrative

Based on the available info, this event is deemed to be a reportable malfunction.No additional patient/event details have been provided to date.Should additional info become available a f/u report will be submitted.(b)(4).

• Brand Name: VISI-FLOW IRRIGATION STARTER SET 1 3/4"
• Type of Device: IRRIGATOR, OSTOMY
• Manufacturer (Section D): CONVATEC, INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4384413
• MDR Text Key: 5127031
• Report Number: 1049092-2015-00002
• Device Sequence Number: 1
• Product Code: EXD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K832299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 022800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2014
• 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: Initial
• Patient Sequence Number: 1