MAUDE Adverse Event Report: CONVATEC DOM. REPUBLIC, INC. SUR-FIT NATURA DRAINABLE POUCH 12" TRANSPARENT W/1-SIDED COMFORT PANEL; POUCH, COLOSTOMY

Model Number 401512

Device Problem Incomplete or Missing Packaging (2312)

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

Event Type  malfunction  

Event Description

It was reported the end user received one box of product with no label on it.No pt complications were reported as a result of this event.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16, 2014.Device (s) list in this report is (are) used for treatment, not diagnosis.Any add'l info received regarding this event after filing this report shall be filed on a supplemental mdr.Analysis is taken from a trending report of eval or adverse events finalized may 2011.The data presented is from three different product applications.The report states that there are no significant trends.

• Brand Name: SUR-FIT NATURA DRAINABLE POUCH 12" TRANSPARENT W/1-SIDED COMFORT PANEL
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOM. REPUBLIC, INC.; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak,quality enginee ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4147908
• MDR Text Key: 4772680
• Report Number: 9618003-2014-11587
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: K780454
• 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: 04/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/06/2017
• Device Model Number: 401512
• Device Lot Number: 2K02918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1