MAUDE Adverse Event Report: CONVATEC INC SUR-FIT NATURA 2 PC UROSTOMY POUCH ACCUSEAL; POUCH, COLOSTOMY

Model Number 401554

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2014

Event Type  malfunction  

Event Description

An end user reported the pouch film stuck together within the first 24 hours and then would not drain to the bottom of the pouch.The end user also stated this caused urine to pool at the top and melt her skin barrier faster.

Manufacturer Narrative

Based on the available info this event is deemed a reportable malfunction.The device was used by the pt, however, there was no report of injury to the pt.No add'l pt/event details have been provided to date.Should add'l info become available, a f/u report will be submitted.A return sample for eval is not expected.Reported to the fda on (b)(4) 2014.

• Brand Name: SUR-FIT NATURA 2 PC UROSTOMY POUCH ACCUSEAL
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC; carretera sanchez, km 18.5; parque indust itabo, s.a. haina; san cristobal 3 ; DR
• Manufacturer Contact: matthew walenciak, assoc dir ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3867999
• MDR Text Key: 4565922
• Report Number: 9618003-2014-00042
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K840166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/21/2016
• Device Model Number: 401554
• Device Catalogue Number: 401554
• Device Lot Number: 1C01130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• 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