MAUDE Adverse Event Report: CONVATEC INC ACTIVELIFE 1- PIECE DRAINABLE CUT-TO-FIT POUCH; POUCH, COLOSTOMY

Model Number 400598

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2014

Event Type  malfunction  

Event Description

The end user's daughter reports that she had difficulty removing the product mass from skin.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.Additional info was requested but, no additional patient or event details have been provided to date.Should additional info become available, a f/u report will be submitted.(b)(4).

Manufacturer Narrative

Additional information was received on september 08, 2015.No previous investigations are available.After a thorough batch review no discrepancies were found.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.(b)(4).

• Brand Name: ACTIVELIFE 1- PIECE DRAINABLE CUT-TO-FIT POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC; carretera sanchez, km. 1.5; parque industrial itabo, s.a.; san cristobal, haina 3 ; DR 3
• Manufacturer (Section G): CONVATEC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4360971
• MDR Text Key: 17266230
• Report Number: 9618003-2014-00115
• 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: Other,other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Model Number: 400598
• Device Lot Number: 4H01320
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 100 YR