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

Model Number 022771

Device Problem Human-Device Interface Problem (2949)

Patient Problems Skin Irritation (2076); Skin Tears (2516)

Event Date 08/13/2011

Event Type  Injury  

Event Description

Report received indicated that end user has on and off irritation around stoma area, 4 days prior to receipt of complaint which is causing bleeding.The last skin barrier he changed looked like it had slid down and caused bleeding at the top of the stoma.The bleeding stopped shortly after the removal of the skin barrier.Will send (b)(4) to prevent irritation.Outcome of pt was not reported.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16, 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 filed on a supplemental mdr.The brand name should read as activelife 1pc-1pc drainable pouch w/ stomahesive (sh).Qual evaluation conducted: this complaint applies to the product name icc code 022771.The lot number could not be obtained.A review of the batch record and retain evaluation could not be performed without a lot number.A review of complaint trend for previous 12 months was performed and there is not indication of complaint trend based on this complaint.

• Brand Name: ACTIVELIFE 1PC-1PC DRAINABLE POUCH W/ STOMAHESIVE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.2; parque industrial; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, dir ; med safety & compliance; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4068033
• MDR Text Key: 4732722
• Report Number: 9618003-2014-10167
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• 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: 08/15/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2011
• 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