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

Model Number 401535

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/05/2014

Event Type  malfunction  

Event Description

A pharmacist reported the pouch film stuck together which prevented urine from filling into pouch.

Manufacturer Narrative

Based on the available info this event is deemed a reportable malfunction.There was no harm to the pt reported.No add'l pt/event details have been provided to date.Should add'l info become available a follow up report will be submitted.A return sample for eval is not expected.(b)(4).

Manufacturer Narrative

Additional information was received on october 23, 2015.No previous investigations are available.After a thorough batch review, no discrepancies were found.There is not enough information to conclude the product did not meet specification and 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.

• Brand Name: SUR-FIT NATURA 2 PC UROSTOMY POUCH W/FOLD FLAP
• Type of Device: URINARY, ILEOSTOMY, 78EXH
• Manufacturer (Section D): CONVATEC INC ; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina 3 ; DR 3
• Manufacturer (Section G): CONVATEC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3970603
• MDR Text Key: 4751692
• Report Number: 9618003-2014-00050
• 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,Consumer,Health Professional,Company Representative,company represent
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/25/2018
• Device Model Number: 401535
• Device Catalogue Number: 401535
• Device Lot Number: 3J01061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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