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

Model Number 175781

Device Problem Human-Device Interface Problem (2949)

Patient Problems Rash (2033); Skin Discoloration (2074)

Event Type  Injury  

Event Description

Report received indicated the patient experienced a red, non-draining rash on the peristomal area from the 9 to 12 o'clock position.The patient experienced the condition during a period of three days prior to complaint receipt.Patient uses past and protective barrier wipes.Recommended stomahesive powder.Patient outcome was not noted.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16 2014.Device listed in this report is 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 evaluations or adverse events finalized (b)(6) 2011.The data presented is from three different product applications.The report states that there are no significant trends.

• Brand Name: ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/ DURAHESIVE (DH)
• Manufacturer (Section D): CONVATEC, INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4020381
• MDR Text Key: 4692822
• Report Number: 1049092-2014-10064
• 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: 06/06/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/18/2016
• Device Model Number: 175781
• Device Lot Number: 1A02344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention