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

Model Number 022752

Device Problem Delamination (2904)

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

Event Type  malfunction  

Event Description

The end user reports 2 of 10 pouches had delamination of the adhesive layers of stomahesive on the right side of the stomahesive within 1 day of wear time.

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.There is 1 additional case associated with this product; therefore a separate fda form 3500a has been generated to address the other case.No additional patient or event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Manufacturer Narrative

Additional information was received on (b)(6) 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 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.

• Brand Name: ACTIVELIFE ONE-PIECE PRE-CUT DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC. ; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina ; DR
• Manufacturer (Section G): CONVATEC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4344922
• MDR Text Key: 5140038
• Report Number: 9618003-2014-00103
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/19/2019
• Device Model Number: 022752
• Device Lot Number: 4B00645
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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: 62 YR