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

Model Number 401544

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/20/2013

Event Type  malfunction  

Event Description

End user reported urine not dropping into bottom of pouch unable to drain.

Manufacturer Narrative

Based on the information provided this event is deemed a reportable malfunction.Practices were discussed with the end user.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available a follow-up report will be submitted.Reported to the fda on (b)(4) 2014.

• 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. 18.5; parque industrial itabo, s.a.; san cristobal, haina 33102 ; DR 33102
• Manufacturer Contact: mary szar, assoc dir ; 200 headquarters park drive; skillman, NJ 08558 ; 9089042450
• MDR Report Key: 3783090
• MDR Text Key: 4439538
• Report Number: 9618003-2014-00011
• 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: 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: 10/07/2018
• Device Model Number: 401544
• Device Catalogue Number: 401544
• Device Lot Number: 3G03600
• 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: 11/01/2013
• 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