MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. S2S/SUR-FIT NATURA 2 PC - 2 PC DRAINABLE POUCH HIGH OUTPUT W/FILTER; POUCH, COLOSTOMY

Model Number 401557

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Report received indicated the pouch leaked from the seam at the bottom of the pouch.No further information was provided and the patient outcome was not reported.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued 04/16/2014.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.Investigation revealed that a probable root cause was determined to be associated with the creation of an arch during the outline weld.A new outline weld tooling design was implemented to prevent reoccurrence."leaked at seams" complaint information will continue to be tracked and evaluated according to convatec, inc.Complaint monitoring procedures.

• Brand Name: S2S/SUR-FIT NATURA 2 PC - 2 PC DRAINABLE POUCH HIGH OUTPUT W/FILTER
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.5, parque industrial; haina, san cristobal 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4138060
• MDR Text Key: 19762051
• Report Number: 9618003-2014-11199
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K780454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/19/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2017
• Device Model Number: 401557
• Device Lot Number: 2D02551
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2012
• Initial Date FDA Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1