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

Model Number 125330

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Skin Discoloration (2074)

Event Type  Injury  

Event Description

Report received indicated the pt developed red itchy skin under entire mass approximately 1 week prior to filing the complaint.The manufacturer sent an alternate product to pt for use.Pt outcome was not noted.

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 info received regarding this event after filing this report shall be field on a supplemental mdr.A review of non conformances related to this complaint investigation was conducted.As a result there was no evidence that any of the manufacturing processes and procedures performed contributed to this event.

• Brand Name: ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/STORMAHESIVE (SH)
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.5; parque industrial; haina, san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american avenue; medical safety & compliance; greenboro, NC 27409 ; 9083779293
• MDR Report Key: 4096429
• MDR Text Key: 4759151
• Report Number: 9618003-2014-10793
• 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: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/03/2016
• Device Model Number: 125330
• Device Lot Number: 1K02963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/03/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other