MAUDE Adverse Event Report: CONVATEC, INC. SUR-FIT NATURA 2 PC UROSTOMY POUCH W/FUT; URINARY, ILEOSTOMY, 78EXH

Model Number 401539

Device Problem Occlusion Within Device (1423)

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

Event Date 06/13/2014

Event Type  malfunction  

Event Description

An end user reported that about after twelve (12) hrs of use the two sides of the pouch film stuck together, sometimes the part underneath the anti-reflux valve, and also the anti-reflux valve itself, thus the urine can barely flow through and accumulates in the upper part of the pouch.The end user then stated he has to change the pouch.The end user also stated that the anti-reflux valve was not blocked before use.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.It was reported that the device was used by an end user, however, there was no report of harm to the end user.It was also reported that the end user has an ileum conduit which means that mucus is continuously produced.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.

Manufacturer Narrative

Additional information was received on june 12, 2015.After a review of the returned product and a detailed batch review no discrepancies were discovered.There is not enough to concluded the product did not meet specification nor perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required and the complaint will be closed.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on july 02, 2015.

• Brand Name: SUR-FIT NATURA 2 PC UROSTOMY POUCH W/FUT
• Type of Device: URINARY, ILEOSTOMY, 78EXH
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; haina, san cristobal 3 ; DR 3
• Manufacturer Contact: matthew walenciak, assoc.dir. ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4023875
• MDR Text Key: 4723216
• Report Number: 9618003-2014-00063
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K840166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 06/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2018
• Device Model Number: 401539
• Device Catalogue Number: 401539
• Device Lot Number: 3H02163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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