MAUDE Adverse Event Report: CONVATEC INC ACTIVELIFE 1PC-1PC DRAINABLE POUCH W/ DURAHESIVE (DH); POUCH, COLOSTOMY

Model Number 125356

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

Patient Problem Skin Tears (2516)

Event Date 04/08/2013

Event Type  Injury  

Event Description

Per the end user's wife, the skin is breaking down around the stoma.There is minimal drainage with the open area.This area has developed a hernia.No further info is available.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 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.Analysis is taken from a trending report of evaluations or adverse events finalized (b)(4) 2011.The data presented is from three different product applications.The report states that there are no significant trends.Brand name: activelife 1pc-1pc drainable pouch w/ durahesive (dh).

• Brand Name: ACTIVELIFE 1PC-1PC DRAINABLE POUCH W/ DURAHESIVE (DH)
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4147504
• MDR Text Key: 4788583
• Report Number: 1049092-2014-11807
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833625
• 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: 07/08/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/18/2018
• Device Model Number: 125356
• Device Lot Number: 3C01636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/08/2013
• Initial Date FDA Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 83