MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE 1 PC DRAINABLE POUCH W/ STOMAHESIVE; POUCH, COLOSTOMY

Model Number 022751

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

Patient Problems Pain (1994); Skin Irritation (2076)

Event Date 03/07/2014

Event Type  Injury  

Event Description

An end user reported she had a skin reaction in which her skin became red and sore 10-20 minutes after application of the device.The end user stated she was given antibiotics from her general practitioner.

Manufacturer Narrative

Based on the available information this event is deemed a serious injury.The end user stated the device she received from her chemist (pharmacist) was out of date, looked different and she believed they were not genuine convatec pouches and were imported.The end user went on to state she has been using the same product for 36 years.She tried another box of devices from a different chemist, she stated they were acceptable and she did not have a skin reaction.The end user was advised that the device, she stated, originally used was not out of date.Upon intake of the end users patient/event details she stated, she would be returning the unused samples, however, they have yet to be received.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on (b)(4) 2014.

• Brand Name: ACTIVELIFE 1 PC DRAINABLE POUCH W/ STOMAHESIVE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; haina, san cristobal 3 ; DR
• Manufacturer Contact: matthew walenciak ; 200 headquarters park drive; skillman, NJ 08558 ; 9083779293
• MDR Report Key: 3763617
• MDR Text Key: 20856473
• Report Number: 9618003-2014-00027
• 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: 03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/24/2018
• Device Model Number: 022751
• Device Catalogue Number: 022751
• Device Lot Number: 3A2263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/12/2014
• Initial Date FDA Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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): Required Intervention