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

Model Number 416729

Device Problems Crack (1135); Product Quality Problem (1506)

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

Event Date 10/27/2014

Event Type  malfunction  

Event Description

It was reported by the end user of "cracked adhesive upon opening".Per the information received, the pouch was changed with no reported harm to the end user.

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No additional pt/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on november 20, 2014.(b)(4).

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 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.

• Brand Name: ESTEEM ONE-PIECE DRAINABLE PRE-CUT POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; san cristobal 3, 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: 4317462
• MDR Text Key: 5133806
• Report Number: 9618003-2014-00096
• 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: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/19/2017
• Device Model Number: 416729
• Device Lot Number: 2C03164
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2014
• Initial Date FDA Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• 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