MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. S2S/SUR-FIT NATURA 2 PC - 2 PC UROSTOMY POUCH W/ ACCUSEAL TAP; BAG, URINARY, ILEOSTOMY

Model Number 401544

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Per the end user, the pouch is leaking to the left of the tap after being closed.No further information is available.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16, 2014.Devices listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.The product was not returned for an evaluation.A batch record review for this lot was performed.No discrepancies or non-conformances were noted in these batch records related to the complaint reported.

• Brand Name: S2S/SUR-FIT NATURA 2 PC - 2 PC UROSTOMY POUCH W/ ACCUSEAL TAP
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.5; parque industrial; haina, san cristobal 33102 ; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4138067
• MDR Text Key: 22138854
• Report Number: 9618003-2014-10301
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K84016
• 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: 10/25/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2015
• Device Model Number: 401544
• Device Lot Number: 0K01016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2010
• 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