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

Model Number 175778

Device Problem Human-Device Interface Problem (2949)

Patient Problem Rash (2033)

Event Type  Injury  

Event Description

End user reports rash under tape border in two spots; on right side and under tape border at the top.Rash itches slightly and is weeping.User saw a dermatologist; used cortisone cream once and it cleared up.Uses water and powder next to stoma.Patient outcome was not reported.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to fda 483 issued april 16, 2014.Devices listed in this report is (are) use for treatment, not diagnosis.Any additional information 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.It is noted that there are blank areas on this form, the information was not provided or is unknown.

• Brand Name: ACTIVELIFE 1 PC -1 PC 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: 4076383
• MDR Text Key: 4831890
• Report Number: 1049092-2014-10386
• 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: 12/05/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/17/2016
• Device Model Number: 175778
• Device Lot Number: 1H02027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• Is the Device Single Use?: No
• 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: 68