MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE 1 PC - 1 PC UROSTOMY CONVEX POUCH W/DURAHESIVE (DH); BAG, URINARY, ILEOSTOMY

Model Number 125365

Device Problem Human-Device Interface Problem (2949)

Patient Problems Skin Irritation (2076); Ulcer (2274)

Event Type  Injury  

Event Description

End user reports that starting about 2 weeks ago she developed 3 areas that blistered and 2 of them have broken leaving a shallow ulcer with serious drainage noted.One is at 10 to 11 o'clock, one at 12 o'clock and the third with blister intact at 1 to 2 o'clock.All three are described as oval and smaller than a dime.The open areas have a moist pale pink wound bed.The blister is reported as containing a milky white fluid.The end user was seen by her doctor who has prescribed bactrim but she reports no improvement.Since starting that she also saw another doctor who had her use nystatin powder.No noted improvement as yet.Further information regarding patient results was not noted.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issues 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.Analysis is taken from a trending report of evaluations or adverse events finalized may 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 UROSTOMY CONVEX POUCH W/DURAHESIVE (DH)
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, director, post ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4101534
• MDR Text Key: 20863739
• Report Number: 1049092-2014-10745
• Device Sequence Number: 1
• Product Code: EXH
• 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: 06/11/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 125365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2012
• 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
• Patient Weight: 62