MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE ONE-PIECE PRE-CUT DRAINABLE POUCH; POUCH, COLOSTOMY

Model Number 022751

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

Patient Problems Erythema (1840); Skin Erosion (2075); Skin Irritation (2076)

Event Date 01/01/2014

Event Type  Injury  

Event Description

The end user reported that he has open area that is irritated around his stoma.He stated that within twenty-four hours his pouch looses its seal around his stoma and cause's his skin to stay red and raw.He saw his physician about two weeks ago for his skin issue and was prescribed two antibiotics and pain medicine (names not provided).

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).Height: (b)(6).

Manufacturer Narrative

Additional information was received on (b)(6) 2015.No previous investigations are available.After a thorough batch review no discrepancies were discovered.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required and the complaint will be closed.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)(6) 2015.

• Brand Name: ACTIVELIFE ONE-PIECE PRE-CUT DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 1.5; parque industrial itabo, s.a.; haina, san cristobal ; DR
• Manufacturer Contact: matthew walenciak, director ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4647888
• MDR Text Key: 5601588
• Report Number: 9618003-2015-00011
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/24/2018
• Device Model Number: 022751
• Device Lot Number: 3E01676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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
• Treatment: ACID REFLUX (NAMES NOT PROVIDED).
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 66