MAUDE Adverse Event Report: CONVATEC DOM. REPUBLIC, INC. ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/STOMAHESIVE (SH); POUCH, COLOSTOMY

Model Number 022771

Device Problem Human-Device Interface Problem (2949)

Patient Problems Rash (2033); Skin Discoloration (2074); Skin Irritation (2076)

Event Date 03/21/2012

Event Type  Injury  

Event Description

Report received indicated the patient developed a red rash with blisters under the tape collar for a two week period.An ostomy nurse recommended that the patient leave paper backing on the tape collar and secure the edges using waterproof tape, but the rash worsened.No further information was provided and the patient outcome was not reported.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issues 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.The batch record review for lot 0j03112 was performed.This product was manufactured according to the quality system and approved procedures in place at the time of manufacturing and packaging.The batch record review found no objective evidence of deviations, non conformances or discrepancies related to the complaint issue reported.The retained samples were examined and tested to determine if there was evidence of manufacturing defect related to the condition reported by the customer.A general visual inspection of the final package was performed.The product contained was consistent with all established specifications.

• Brand Name: ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/STOMAHESIVE (SH)
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOM. REPUBLIC, INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; haina, san cristobal 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director, post ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4101535
• MDR Text Key: 4718903
• Report Number: 9618003-2014-10586
• 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: 04/04/2012

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 Expiration Date: 10/04/2015
• Device Model Number: 022771
• Device Lot Number: 0J03112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2012
• Initial Date FDA Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2010
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 75