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

Model Number 022771

Device Problem Human-Device Interface Problem (2949)

Patient Problem Skin Tears (2516)

Event Date 04/23/2012

Event Type  Injury  

Event Description

It was reported that a patient had a skin tear around the stoma after removal of an appliance.No additional information was provided.Patient outcome was not reported.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued 04/16/2014.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 1a04116 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, nonconformances or discrepancies related to the complaint issue reported.The retained samples were examined and tested to determine there was evidence of a manufacturing defect related to the condition reported by customer.A general visual inspection of the final package was performed.The product contained was consistent with all established specifications.(b)(4).

• Brand Name: ACTIVELIFE 1 PC - 1PC DRAINABLE POUCH W/STOMAHESIVE (SH)
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.2; parque industrial, haina; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak,director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4053535
• MDR Text Key: 4730751
• Report Number: 9618003-2014-10633
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K780454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/23/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/03/2016
• Device Model Number: 022771
• Device Lot Number: 1A04116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention