MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVLIFE 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 Erythema (1840); Itching Sensation (1943); Burning Sensation (2146)

Event Date 04/05/2012

Event Type  Injury  

Event Description

Report received indicated that the first time the pt applied the 1 piece pouch there was a little itching and burning sensation under the mass only.When the appliance was changed the next day, the pt felt a greater degree of itching and burning and had to remove the new appliance after one day of wear.The skin was splotchy, red, dry and burning, especially at the bottom and both side under the mass only.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 add'l info received regarding this event after filing this report shall be filed on a supplemental mdr.A lot number could not be obtained therefore a review of the batch record data could not be performed without a valid lot number.(b)(4).No events or capas relating to the complaint issue were found in the global non-conformance reporting system for the previous 12 months of case creation.It is noted that there are blank areas on this form, the info was not provided or is unk.

• Brand Name: ACTIVLIFE 1 PC - 1 PC DRAINABLE POUCH W/ DURAHESIVE (DH) PLUS
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carr. sanchez, km. 18.5; parque industrial; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4059045
• MDR Text Key: 19087317
• Report Number: 9618003-2014-10601
• 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: 04/10/2012

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/10/2012
• Initial Date FDA Received: 08/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 126