MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. S4S/SUR-FIT NATURA 2PC-2PC DRAINABLE POUCH - INVISCLOSE DRAIN PCH W/FILTER; POUCH, COLOSTOMY

Model Number 411310

Device Problem Human-Device Interface Problem (2949)

Patient Problems Irritation (1941); Itching Sensation (1943)

Event Type  Injury  

Event Description

It was reported that a patient had a red, irritated and itchy area inferior to stomal area where pouch is touching the skin.The patient also reported "there is no skin fold in area; area under dry; intact and not effected" no additional information was provided.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: S4S/SUR-FIT NATURA 2PC-2PC DRAINABLE POUCH - INVISCLOSE DRAIN PCH W/FILTER
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4059339
• MDR Text Key: 4866374
• Report Number: 9618003-2014-10650
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 04/30/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/25/2016
• Device Model Number: 411310
• Device Lot Number: 1M01329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 86