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

Model Number 401512

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); No Code Available (3191)

Event Date 05/06/2012

Event Type  Injury  

Event Description

The patient reported she developed a "bright red rash" under the pouch.The rash has "whitehead pimples that drain." the rash has reportedly spread to other parts on abdomen beyond area where pouch touches.The patient has experienced this condition during a period of six months prior to complaint receipt.

Manufacturer Narrative

Analysis is taken from a trending report of evaluations or adverse events finalized may 2011.The data presented is from three different product applications.The report states that there are no significant trends.Convatec is submitting this report as a result of remediation activities related to the fda issues april 16, 2014.Device (s) listed in this report is (are) used for treatment, no diagnosis.Any additional info received regarding this event after filing this report shall be filed on a supplemental mdr.

• Brand Name: SUR-FIT NATURA DRAINABLE POUCH 12" TRANSPARENTW/ 1-SIDED COMFORT PANEL
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; haina, san cristobal 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4101797
• MDR Text Key: 4699876
• Report Number: 9618003-2014-11057
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780454
• 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: 11/06/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 401512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 113