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

Model Number 401544

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Report received indicated that leakage occurred after a fresh pouch was placed on the patient 2 hours before sleep.Patient notice leakage when woke up to wet clothes, but could not specify leakage position accurately.Because clothes over tap were wet, patient considers leakage was from the tap area.Patient outcome was not reported.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16, 2014.Device(s) 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.

• Brand Name: S2S/SUR-FIT NATURA 2 PC - 2 PC UROSTOMY POUCH W/ ACCUSEAL TAP
• Type of Device: URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4174695
• MDR Text Key: 5160856
• Report Number: 9618003-2014-10527
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K840166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/02/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/12/2016
• Device Model Number: 401544
• Device Lot Number: 1G00612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention