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

Model Number 175780

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

Patient Problems Inflammation (1932); Itching Sensation (1943); Skin Irritation (2076)

Event Type  Injury  

Event Description

Patient reported circumferential redness and multiple fluid filled areas under the entire mass of her device.End-user explained she developed an itch and area became sore upon touch as the climate temperature increased.Patient used adhesive powder to the peristomal area and used a drainable pouch with stoma adhesive skin barrier.Patient was recommended by health professional to continue to apply neutralizing agent to her peristomal skin until the breakdown resolved.The end user subsequent outcome was not reported.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 482 issued april 16, 2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.Activelife convex 1-piece pre-cut drainable pouch w/durahesive skin barrier w/1-sided comfort panel and tape collar 12" transparent.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
• 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: 4147532
• MDR Text Key: 4770538
• Report Number: 1049092-2014-11754
• 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: 06/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 175780
• Device Lot Number: 3A01085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Weight: 82