MAUDE Adverse Event Report: CONVATEC ACTIVELIFE 1 PC- 1 PC DRAINABLE POUCH W/ DURAHESIVE (DH) PLUS; POUCH, COLOSTOMY

Model Number 400598

Device Problem Human-Device Interface Problem (2949)

Patient Problems Rash (2033); Skin Discoloration (2074)

Event Date 03/26/2012

Event Type  Injury  

Event Description

Report received indicated the pt developed a red rash under the wafer ten days after receiving chemotherapy.No further info was provided and the pt 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 info received regarding this event after filing this report shall be filed on a supplemental mdr.A 12 month review of complaint listings for rash/itch under mass icc code (b)(4) found 1 case reported.No events relating to the complaint issue were found in the global non-conformance reporting system for the previous 12 months of case creation.Based on the evaluation conducted.No future investigation is required.

• Brand Name: ACTIVELIFE 1 PC- 1 PC DRAINABLE POUCH W/ DURAHESIVE (DH) PLUS
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, dir ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4059292
• MDR Text Key: 4865904
• Report Number: 9618003-2014-10575
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K9780454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/29/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 400598
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention