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

Model Number 400599

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

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 04/02/2012

Event Type  Injury  

Event Description

Report received indicated that the pt developed an itchy red rash under the region located between the eakin seal and the tape border area.Report also noted that the fluid in the blister initially appeared bloody and it has now developed into a "bumpy sometimes moist rash".Prior to the receipt of this complaint, the pt used the product for over five years without incident.Courses of treatment prescribed include various mediated powder.If the symptoms progress, pt will seek further treatment from her dermatologist.Further info regarding pt outcome was not available.

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 review of nonconformances related to this complaint investigation was conducted during the initial 12 month reported period.As a result there was no evidence that any of the manufacturing processes and procedures performed contributed to this event.

• Brand Name: ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/DURAHESIVE (DH) PLUS
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; 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: 4071694
• MDR Text Key: 20454626
• Report Number: 9618003-2014-10751
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780454
• 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: 06/14/2012

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: 400599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2012
• Initial Date FDA Received: 08/28/2014
• 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