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

Model Number 401544

Device Problem No Flow (2991)

Patient Problem No Information (3190)

Event Date 12/20/2013

Event Type  malfunction  

Event Description

End user reported urine not dropping into bottom of pouch; unable to drain.The reporter states they had to remove to dispel the urine.The pouch stuck together and would not become unstuck.

Manufacturer Narrative

Based on the info provided this event is deemed a reportable malfunction.Practices were discussed with the end user.No add'l pt/event details have been provided to date.A return sample for eval is not expected.Should add'l info become available, a f/u report will be submitted.

• Brand Name: SUR-FIT NATURA 2PC UROSTOMY POUCH W/ ACCUSEAL
• Type of Device: URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: mary szaro, assoc, dir. ; 200 headquarters park drive; skillman, NJ 08558 ; 9089042450
• MDR Report Key: 3670263
• MDR Text Key: 4344099
• Report Number: 9618003-2014-00013
• Device Sequence Number: 1
• Product Code: EXB
• 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: 12/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/23/2018
• Device Model Number: 401544
• Device Catalogue Number: 401544
• Device Lot Number: 3G02248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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