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

Model Number 175777

Device Problem Human-Device Interface Problem (2949)

Patient Problem Inflammation (1932)

Event Type  Injury  

Event Description

Report received indicated the pt had irritated skin under the tape collar.It resolved and then recently recurred.The pt was in a warm climate.No further info was provided and the pt outcome was not reported.

Manufacturer Narrative

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 PIUCH W/ DURAHESIVE (DH)
• Type of Device: POUCH, 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: 4023880
• MDR Text Key: 4723217
• Report Number: 1049092-2014-10565
• 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: 03/22/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 175777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention