MAUDE Adverse Event Report: CONVATEC INC ACTIVELIFE 1PC-1PC DRAINABLE POUCH W/STOMAHESIVE(SH); POUCH, COLOSTOMY

Model Number 022771

Device Problem Human-Device Interface Problem (2949)

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

Event Date 08/11/2011

Event Type  Injury  

Event Description

Report received from the end user states that she experienced itching under the border for four months.The end user has always purchased the same product and the itching under the border has never happened before.The pts subsequent outcome 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 information received regarding this event after filing this report shall be filed on a supplemental mdr.A batch record review was performed and no discrepancies were found related to the complaint.Retained product was evaluated and appeared to be in normal condition.A review of complaint trend for the previous 12 months was performed and there is no indication of a complaint trend.

• Brand Name: ACTIVELIFE 1PC-1PC DRAINABLE POUCH W/STOMAHESIVE(SH)
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american ave; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, dir ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4121356
• MDR Text Key: 19590549
• Report Number: 9618003-2014-10170
• 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: Foreign,Consumer,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/12/2011

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: 022771
• Device Lot Number: 0F03068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 57