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

Model Number 125353

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

Patient Problems Itching Sensation (1943); Rash (2033); Skin Discoloration (2074)

Event Type  Injury  

Event Description

Report provided by the end user states that they have experienced a rash under the entire tape border.The rash is described as red, flat and slightly excoriated by the home health nurse and does not extend beyond the tape border.The end user reports the rash to be slightly painful and itchy.The appliance is remaining in place for less than a day.The end user is currently using nystatin and triamcinolone cream as prescribed by the home healthcare provider.The end user was instructed in skin care and crusting techniques with an ostomy powder and barrier wipes.The end user was advised to try the product without a tape border.The end users subsequent outcome was not reported.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued on 04/16/2014.Device (s) listed in this report is (are) used for treatment, not 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 evals or adverse events finalized on (b)(4) 2011.The data presented is from three different product applications.The report states that there are no significant trends.Event date: unk.

• 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, dir, qlty engr ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4147601
• MDR Text Key: 4782281
• Report Number: 1049092-2014-11732
• 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: 06/13/2013

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: 01/31/2018
• Device Model Number: 125353
• Device Lot Number: 3A03934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2013
• Initial Date FDA Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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): Required Intervention
• Patient Weight: 78