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

Model Number 022765

Device Problem Human-Device Interface Problem (2949)

Patient Problem Rash (2033)

Event Type  Injury  

Event Description

It was reported that end user observed red, pimple like areas that itch under tape border and sometimes outside the border.The end user experienced the condition during a period of two to three days prior to complaint receipt.Patient outcome was not reported.

Manufacturer Narrative

Convatec is submitting the report as a result of remediation activities related to the fda 483 issued april 16 2014.Devices listed in this report are used for treatment, not diagnosis.Any additional info received regarding this event after filing this report shall be filed on a supplemental mdr.The batch record review for lot 0a03604 was performed.No discrepancies were noted in this batch record related to the complaint reported.The retained product was evaluated and the evaluation results are as follows: the samples were visually inspected and all samples appeared to be in normal condition.Leak testing was performed and passes the established specification.

• Brand Name: ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/ STOMAHESIVE (SH)
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.5; parque industrial; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, dir ; 211 america ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4053536
• MDR Text Key: 4908376
• Report Number: 9618003-2014-10366
• 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: 11/28/2011

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: 01/17/2015
• Device Model Number: 022765
• Device Lot Number: 0A03604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 86