MAUDE Adverse Event Report: CONVATEC INC ACTIVELIFE 1 PC - 1 PC UROSTOMY CONVEX POUCH W/ DURAHESIVE (DH); COLLECTOR, OSTOMY

Model Number 125368

Device Problem Human-Device Interface Problem (2949)

Patient Problems Skin Discoloration (2074); Skin Irritation (2076)

Event Date 05/24/2011

Event Type  Injury  

Event Description

Report received indicated the pt experienced redness and discomfort on the skin of the right thigh underneath the pouch film.The pt experienced the condition during a period of three days prior to complaint receipt.Pt has used product for 20 years.Pt cleanses area and applies protective dressing.Pt outcome was not noted.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda (b)(4) issued 04/16/2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any add'l 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 if 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 info was not provided or is unk.

• Brand Name: ACTIVELIFE 1 PC - 1 PC UROSTOMY CONVEX POUCH W/ DURAHESIVE (DH)
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, dir, post mark ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3987390
• MDR Text Key: 16176109
• Report Number: 1049092-2014-10042
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/24/2011

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 Model Number: 125368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2011
• Initial Date FDA Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention