MAUDE Adverse Event Report: CONVATEC, INC. VISI-FLOW IRRINGATION STARTER SET 1 3/4" 45M; 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 01/07/2015

Event Type  malfunction  

Event Description

The end user reported black residue in the irrigator tube.It was thought to be mold.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.No add'l pt/event details have been provided to date.Should add'l info become available, a f/u report will be submitted.Reported to fda on (b)(4) 2015.

• Brand Name: VISI-FLOW IRRINGATION STARTER SET 1 3/4" 45M
• Type of Device: IRRIGATOR, OSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew welanciak, assoc, dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4441836
• MDR Text Key: 5387465
• Report Number: 1049092-2015-00031
• 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: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• 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: 01/08/2015
• 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: Initial
• Patient Sequence Number: 1