MAUDE Adverse Event Report: CONVATEC, INC. SUR-FIT NATURA 2PC UROSTOMY POUCH S/ACCUSEAL; BAG, URINARY, ILEOSTOMY

Model Number 401545

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2014

Event Type  malfunction  

Event Description

An end user reported that he had two (2) pouches where urine would not drain through antireflux panel or only drained very slowly.The end user also stated he will not use the rest of the box and cannot understand why the urine is not funneling to the pouch bottom.

Manufacturer Narrative

Based on the available information this event is deemed a reportable malfunction.The device was used by the patient, however there was no report of injury to the patient.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.A return sample for evaluation is not expected.

• Brand Name: SUR-FIT NATURA 2PC UROSTOMY POUCH S/ACCUSEAL
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina ; DR
• Manufacturer Contact: matthew walenciak, interim assoc. ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3956918
• MDR Text Key: 4612568
• Report Number: 9618003-2014-00060
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K840166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/18/2018
• Device Model Number: 401545
• Device Catalogue Number: 401545
• Device Lot Number: 3K03189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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