MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE 1PC UROSTOMY CONVEX POUCH W/DURA; POUCH, COLOSTOMY 78 EZQ

Model Number 175797

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

Patient Problems Fainting (1847); Hypersensitivity/Allergic reaction (1907); Swelling (2091)

Event Date 02/14/2014

Event Type  Injury  

Event Description

End user reported that she appeared to have an allergic reaction to the pouch film of the s916; not the wafer.

Manufacturer Narrative

Based on the info provided this event is deemed a reportable malfunction.She reported that she is sensitive and is allergic to many things and felt that the pouch film got into the stoma and may have caused the reaction.She further reports experiencing swelling of the face, pores, and tongue.As well as red eyes, pushing feeling in her vagina, and feeling faint.She also reported that this is similar to what she has experienced with other products.No additional info was provided on the other products the complaint mentioned experiencing these similar issues with.She reported that the device was removed after twenty (20) minutes.Request for additional pt/event and product return info was sent on 02/14/2013, 02/27/2014 and 03/07/2014.No additional event additional details have been provided to date.Should a return sample or additional info become available a follow-up report will be submitted.

• Brand Name: ACTIVELIFE 1PC UROSTOMY CONVEX POUCH W/DURA
• Type of Device: POUCH, COLOSTOMY 78 EZQ
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: mary szaro, assoc. director ; 200 headquarters park drive; skillman, NJ 08558 ; 9089042450
• MDR Report Key: 3961801
• MDR Text Key: 4608998
• Report Number: 1049092-2014-00068
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K833625
• 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: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/27/2017
• Device Model Number: 175797
• Device Catalogue Number: 175797
• Device Lot Number: 2G01951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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