MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ESTEEM + ONE PIECE DRAINABLE CUT-TO-FIT POUCH; POUCH, COLOSTOMY

Model Number 416719

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 10/29/2014

Event Type  malfunction  

Event Description

A pharmacist reported that an end user returned seven unused pouches out of a box of ten due to the adhesive not adhering to the skin, which resulted in falling off and leaking from the stoma.

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(5).

Manufacturer Narrative

Additional information was received on (b)(6) 2015.Batch record review was performed and a previous investigation is applicable to this complaint which has been closed.Therefore, this complaint will be closed and no further actions are required.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 CUT-TO-FIT POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; haina, san cristobal 33102 ; DR 33102
• Manufacturer (Section G): CONVATEC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4291016
• MDR Text Key: 20661868
• Report Number: 9618003-2014-00101
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,consumer,foreign,oth
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/13/2017
• Device Model Number: 416719
• Device Lot Number: 2L00448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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: 19 YR
• Patient Weight: 63