MAUDE Adverse Event Report: CONVATEC INC ACTIVELIFE 1 PC-1 PC DRAINABLE POUCH W/STOMAH; POUCH, COLSTOMY

Model Number 125330

Device Problem Human-Device Interface Problem (2949)

Patient Problem Abscess (1690)

Event Date 01/23/2012

Event Type  Injury  

Event Description

Report received indicated that mother called on behalf of end user to advise abscess of unknown size present near stoma necessitating increased frequency of appliance change.Patient 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 additional information received regarding this event after filing this report shall be filed on a supplemental mdr.The batch record review for lot 1j00923 was performed.No discrepancies were noted in these batch records 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.It is noted that there are blank areas on this form, the information was not provided or is unknown.

• Brand Name: ACTIVELIFE 1 PC-1 PC DRAINABLE POUCH W/STOMAH
• Type of Device: POUCH, COLSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: matthew walenciak, director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3986432
• MDR Text Key: 4819211
• Report Number: 9618003-2014-10505
• 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: 02/23/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/10/2016
• Device Model Number: 125330
• Device Lot Number: 1J00923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2011
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 88