MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 1-PIECE DRAINABLE CUT-TO-FIT POUCH; POUCH, COLOSTOMY

Model Number 400598

Device Problem Human-Device Interface Problem (2949)

Patient Problem Rash (2033)

Event Type  Injury  

Event Description

The patient reported they developed a rash under the tape portion of the wafer.The rash has persisted for approximately 7 days.The patient reportedly changes the device every 2-3 days and cleanses with water or liquid soap.No further information was reported.

Manufacturer Narrative

The lot number could not be obtained.A review of the batch record and retain evaluation could not be performed without a lot number.A review of complaint trend for previous 12 months was performed and this is the only complaint of this type for this icc code.There is no indication of complaint trend based on this review.No nonconformance or capas relating to the primary reason for contact for this icc were found in the nonconformance reporting system for the previous 12 months of case creation.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.

• Brand Name: ACTIVELIFE 1-PIECE DRAINABLE CUT-TO-FIT POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; san cristobal, haina
• Manufacturer Contact: matthew walenciak, director ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4059312
• MDR Text Key: 4907349
• Report Number: 9618003-2014-10477
• Device Sequence Number: 1
• Product Code: EXB
• 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: 02/07/2012

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: 400598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2012
• Initial Date FDA Received: 08/18/2014
• 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
• Patient Weight: 79