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

Model Number 650829

Device Problem Human-Device Interface Problem (2949)

Patient Problems Itching Sensation (1943); Rash (2033); Skin Discoloration (2074)

Event Type  Injury  

Event Description

Report received indicated the pt experienced a red, dry, itchy rash underneath the device.Rash is worse underneath the adhesive border.The pt experienced the condition during a period of 4-6 weeks prior to complaint receipt.Pt preps with powder and anti-sting spray.Patient treated with antifungal powder with little effect.Pt used cortisone cream and removed the tape border.Rash diminished but still extant under the device advised to perform patch test.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 (b)(4) 2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional info received regarding this event after filing this report shall be field on a supplemental mdr.The submission of this report by convatec or related info to the fda and its release by the fda, does not reflect an admission by convatec, or a conclusion by the fda that this report or related info that convatec, their employees, or the convatec device caused or contributed to the reportable event.Analysis is taken from a trending report of evaluations or adverse events finalized (b)(4) 2011.The data presented is from three different product applications.The report sates 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 POUCH W/DURAHESIVE (DH)
• Type of Device: BAG, URINARY , ILEOSTOMY
• Manufacturer (Section D): COVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4012491
• MDR Text Key: 20658557
• Report Number: 1049092-2014-10667
• 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: 05/04/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 650829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2012
• 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: 113