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

Model Number 022771

Device Problem Human-Device Interface Problem (2949)

Patient Problems Skin Discoloration (2074); Burning Sensation (2146)

Event Type  Injury  

Event Description

Report received indicated the pt experienced red, burning skin underneath the mass.The pt experienced the condition during an unk period prior to complaint receipt.Pt changes device every two days and preps with no-sting spray.Pt switched to competitor device.Pt outcome was not noted.

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.Brand name: activelife 1 pc- 1 pc drainable pouch w/ stomahesive (sh).Lot number provided is invalid.Sample analysis could not be performed.A 12 month review of complaint listings for skin discomfort under mass icc code 022771 found only 1 case reported.No events or capas relating to the complaint issue were found in the global non-conformance reporting sys for the previous 12 months of case creation.

• Brand Name: ACTIVELIFE 1 PC-1PC DRAINABLE POUCH
• 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: 4068009
• MDR Text Key: 21729217
• Report Number: 9618003-2014-10662
• 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: 05/03/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022771
• Device Lot Number: 1E40255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2012
• Initial Date FDA Received: 08/11/2014
• 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