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

Model Number 022771

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Reaction (2414)

Event Type  Injury  

Event Description

The patient's husband reported the patient's skin is blotchy and itchy under the tape border.No additional information was 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 filling this report shall be filed on a supplemental mdr.

• Brand Name: ACTIVELIFE 1 PC-1PC DRAINABLE POUCH W/STOMAHESSIVE (SH)
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC; haina, san cristobal
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4029657
• MDR Text Key: 4846832
• Report Number: 9618003-2014-10111
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/05/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• 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: 07/05/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 64